Surgical Recall Pdf Free Download
Roxanna Bornemann
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The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use. Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.
Asensus Surgical Inc. is recalling the Senhance Surgical System due to malfunctions that cause unintended movement of the robotically-assisted surgical device. This issue presented itself as an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) where the LIA rotated continuously in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. The Senhance System is designed with emergency stop capabilities to stop this issue if observed.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
Build the Confidence for Success on Your Exams and in the Operating Suite!
Written in a rapid-fire question-and-answer format ideal for learning on the go, this best-selling clerkship resource covers both general surgery and surgical subspecialties and provides accurate, on-the-spot answers to the questions most likely encountered during rotations and on the shelf exam. This enhanced 9th edition reflects the latest advances in key areas, as well as additional Rapid-Fire Review questions and new Rapid-Fire Vignettes to prepare students for success on exams and beyond.
Thoroughly updated for its Fifth Edition, this reference for third and fourth year medical students on surgical clerkships enables quick study in a rapid-fire Q&A format. A perfect fit for a lab coat pocket, this book is commonly used as a quick review prior to surgical rounds as well as for board review.
Purchasers of this edition will get both the print book and access to MP3 audio files of the entire text. All Q&A material will also be posted online in the form of electronic flashcards for self-quizzing.
Embryo culture media is a pivotal component in the delicate process of IVF, intended to provide an optimal environment for the development of embryos. In essence, the culture media is the material in the petri dish where eggs are fertilized with sperm and then develop into embryos. This solution is meant to mimic the environment in the womb. It is crucial to supporting healthy development. Even small deviations in pH, nutrients, or the presence of contaminants can harm or destroy the fragile developing embryos.
The impact of such a recall and ensuing scheme to bury the truth extends far beyond the immediate financial implications for clinics and individuals. Couples undergoing fertility treatments invest not only substantial financial resources but also their emotional and physical well-being, hoping to realize their dreams of parenthood. The repercussions of a failed IVF cycle caused by defective culture media, and then exacerbated by concealment of the truth, cause profound emotional distress. For many of our clients, this tragedy may have severely limited their chances of becoming parents.
Dr Notes is a website where you can store any medical book, notes, exams, and recalls online for easy sharing. The idea behind the site is to make it more convenient for the medical field staff to share large amounts of eBooks online.
Ever wish you could study on the run, in the car, or while you are running errands? Now you can with the audio version of the popular Surgical Recall! With rapid-fire questions and answers in downloadable MP3 files, you can have this valuable resource available wherever you go to help memorize and recall the most important surgical facts. Files can be used on any digital audio playback device, and they contain all the same content as the print or PDA version of Surgical Recall, Fourth Edition. Surgical Recall Audio is just the tool you need to shine on your surgical rotation!
The recalls of these devices on the Device Recall Dashboard reflect the Committees interpretation of the publicly available device database, and do not imply liability of safety, effectiveness, or approval of use by AAOS. Clinicians should use their own, independent medical judgment, in addition to open discussion with the patient, when developing patient care recommendations and device selection.
While the Committee intends to update the Dashboard quarterly, AAOS makes no representations or warranties that the Dashboard contains all relevant device information and/or the most up-to-date status information. Clinicians are encouraged to independently confirm whether a Class 1 or 2 device has been subject to a recall. Use of the Dashboard is subject to applicable AAOS policies, including by not limited to the AAOS Privacy Policy and Terms of Use.
Orthopaedics makes up the single largest specialty of medical devices and accounts for approximately 20 percent of all recalls issued by the FDA. It is critical that orthopaedic surgeons understand their role in improving patient safety through device surveillance.
I found the CooperSurgical recall notice (pdf download) online from the national authorization and supervisory authority Swissmedic. The recall was dated December 5, 2023, and lists their global media, which is used to culture embryos from days 1 to 5.
Since originally posting this in early January 2024, there have been more lawsuits filed, including one law firm which is representing about 60 clients, and another public law firm which is representing more. Additionally, a class action lawsuit has been filed in Canada against CooperSurgical.
Major traumatic injury frequently causes hemodynamic instability that necessitates reducing the usual dose of anesthetic given for surgery. Nevertheless, a lower dose may be sufficient to provide anesthesia because of conditions present in trauma victims that are known to reduce anesthetic requirement (hypotension, hypothermia, and acute alcohol intoxication). To determine the incidence and patient perception of recall of surgery, 51 patients were interviewed after surgery for major trauma. Patients were assigned to one of two groups. Thirty-seven patients were given an anesthetic for endotracheal intubation and had continuous or almost continuous anesthesia during surgery. Of the four who recalled surgery (11%), two considered this awareness their worst hospital experience. Fourteen other patients, who were more severely injured, were not given an anesthetic for endotracheal intubation and/or for 20 or more consecutive minutes during surgery. Of the six patients in this group who recalled surgery (43%), two considered this awareness their worst hospital experience. No condition known to reduce anesthetic requirement did so reliably enough that recall of surgery did not occur when the anesthetic dose had to be reduced because of major trauma. The authors conclude that the incidence of recall of surgery in victims of major trauma is considerable, and that reducing the dose of anesthetic increases this incidence, despite the presence of conditions known to reduce anesthetic requirement.
This issue resulted in an uncontrolled arm motion of the Laparoscope Instrument Actuator (LIA) meaning the LIA rotated endlessly in one direction after the Surgeon removed the engagement of teleoperation on the Senhance System. The device does have a built-in failsafe to perform an emergency stop if this occurs.
The recalled device was designed for laparoscopic surgical procedures and laparoscopic gynaecological surgery. It uses reusable instruments and an open-platform architecture strategy that allows hospitals to use existing technology. The company also claims it reduces time and cost-per-procedure when compared to manual laparoscopy.
Asensus recalled its Senhance system due to malfunctions causing unintended movement of the robotically-assisted surgical device. The issue presented itself as an uncontrolled arm motion of the laparoscope instrument actuator (LI). In this case, the LIA rotated continuously in one direction after the surgeon removed the engagement of teleoperation on the system.
The company designed Senhance with emergency stop capabilities to stop this issue if observed. Asensus reported no patient impact or harm due to this issue to date. However, the potential for critical tissue trauma remains possible.
Asensus designed Senhance for use in general laparoscopic and laparoscopic gynecological procedures. The company won FDA clearance for the system in 2017. Since then, it secured expanded indications, deals with Google and Nvidia, and hospital placements in Japan, Germany, Switzerland and Russia.
Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swho...@wtwhmedia.com.
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Written in a rapid-fire question-and-answer format, Surgical Recall is a best-selling, high-yield reference for clerkship students. Covering both general surgery and surgical subspecialties, this port...
Academic Intranet
UTMC student website offers instructional videos pertaining to the required procedures for The Department of Surgery. Look under the Curriculum List/College of Medicine, Third and Fourth Year/Clinical Skills.