According to the reporter, two devices had issues during total laparoscopic hysterectomy.The devices would close on tissue, but tog gling was difficult.While closing the vaginal cuff, suture was passed through, jaws were closed, but one toggle broke off as surgeon attempted to exchange needle from one jaw to another; this happened on each reported instrument.The devices were also difficult to unload.Both handle and suture reload were replaced to complete the case.There was no patient injury.
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted no witness marks from the needle tip impacting the beveled walls, the flat pins were properly oriented, and there was a broken piece of toggle switch inside each instrument handle and one of the external levers on the toggle switch was broken off of each instrument.It was reported that the device broke, and the device was difficult to toggle and unload.The reported issues were confirmed.The root cause of the observed condition was determined to be a result of a component failure.The toggle switch was broken.The most likely root cause of the observed condition is wheel component strength.The wheel is necessary for opening of closing of the jaws of the device and if damaged can create difficulty or ceasing of this motion.A process improvement has been initiated to address this issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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