According to the reporter, on a laparoscopic hysterectomy, while closing the vaginal cuff, the needles of 2 handles disengaged within the first two or three passes to the tissue.The needles stayed in the vaginal cuff attached by the suture.The needles were retrieved with laparoscopic graspers.Another device was used to complete the case.There was no patient injury.
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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 wall.No shearing or deformation was observed around the toggle switch or on the flat pin.Microscopic inspection of the flat pin found it to be properly oriented.No abnormalities were observed for the center rod.No abnormalities were observed for the metal blades of the instrument.It was reported that the needle fell out of the jaws of the device.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The evaluation detected an unreported condition: the blades of the instrument were bent.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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