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Model Number ABSTACK15 |
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 09/17/2018 |
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 a lparoscopic inguinal hernia repair, during mesh fixation, the stem was split without exerting force, the tip broke, which restricted the output of tacks.A new device was requested 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.Functional testing was precluded due to the observed condition of the device.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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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