Model Number ABSTACK30 |
Device Problems
Break (1069); Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during laparoscopic inguinal hernia repair, no tacks able to be fired normally from the device.The device also had broken shaft.They used different device to complete the case.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted the tube shaft was broken.Tacks were visible in the shaft.The handle of the instrument could be actuated but tacks did not deploy.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of these conditions may occur if the instrument is applied with excessive force or side load, causing excess torque on the rotating helices and tube shaft which can cause poor tack penetration.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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