According to the reporter, during a procedure, device not cutting sufficiently.The knife did not fire and the knife release lever broke off while using.The broken piece did not fall into patient's cavity.No x-ray or medical intervention needed.Another device worked successfully.There was no patient injury.
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D10 concomitant product: vlft10gen ft series energy platformx1 (serial#: unknown).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the knife trigger had broken off.The broken piece was returned.The damage was traced to misuse.Likely due to a drop.It was reported that the device not cutting sufficiently.The knife did not fire and the knife release lever broke off while using.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.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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