Olympus reviewed the following literature: "is 3d faster and safer than 4k laparoscopic cholecystectomy? a randomised-controlled trial." literature summary: this randomized controlled study discussed about is 3d faster and safer than 4k laparoscopic lecystectomy.Patients undergoing laparoscopic cholecystectomy were randomised to 3d hd or 4k laparoscopy.Operative videos were recorded, and the time from gallbladder exposure to separation from the liver (minus on table cholangiogram) was calculated.There were 120 patients were randomized and out of that, 109 were analyzed.There were no reduction in operative time was detected with 3d hd compared to 4k laparoscopy.Stone spillage occurred more frequently with 3d hd, but there were no other dif differences in individual error rates.The study was concluded that a 3d hd laparoscopic system did not reduce operative time or error scores during laparoscopic cholecystectomy compared with a new 4k imaging system. type of adverse events/number of patients: gallbladder injury with stones spilled (n=1), livery injury with bleeding (n=5), cystic artery injury (n=6), perforated gallbladder with suture closure.30-day complications/re-admission? post op pain/reattendance (n=2), intraoperative dysrhythmia (n=1), urinary retention (n=1).Gallbladder injury with bile spilled (n=16), diathermy liver injury (n=11), clip fell into abdomen (n=2).Since the literature described "visera 4k uhd system", we selected "otv-s400" and "clv-s400" as representative products.Two complaints (otv-s400 and clv-s400) are created for mdr.This is 2 of 2 reports for this article.
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This supplemental report is being submitted to provide the legal manufacturer's investigation.New information added to the following fields: h6, h10; correction to initial report b5 and h6.B5, h6: upon further evaluation by the legal manufacturer, the following events have been determined to be non-serious: injury to gallbladder with bile spilled -(16), liver injury by diathermy -(11), misplaced clip fallen into abdomen -(2).The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.
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