According to the reporter, halfway through hemmorrhoidectomy, the device was very difficult to cut with; not cutting sufficiently and felt forced.Knife blade could not advance.Would sometimes get caught and stuck, jaws were forced open.The device was applied to hemorrhoids tissue at that time, it was removed easily, had to activate knife multiple times to get to return to normal.The device was cleaned every couple seals.Another device was used successfully.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 that there was eschar build-up on the seal plates and in the knife track.Functional testing noted that the device's jaw opening and closing mechanism was functioning properly.The weld integrity of the device was inspected and was found to be within specification.Eschar build up prevented the knife from advancing.The eschar is enough to dislodge the knife as well.It was reported that the jaws were difficult to open, there was a device cutting issue, the knife blade did not advance and did not retract.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: keep the instrument jaws clean.Build-up of eschar may reduce the seal or cutting effectiveness.D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial#unknown) 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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