Model Number ABSTACK30 |
Device Problems
Break (1069); Failure to Advance (2524); Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2018 |
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 laparoscopic inguinal hernia procedure, after the fifth shot, the surgeon noticed a great resistance in the tacker, soon identified that it was broken.A new device was used to complete the case.No injury.
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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 laparoscopic inguinal hernia procedure, after the fifth shot, the surgeon noticed a great resistance in the tacker, soon identified that the shaft had broken into smaller pieces.A new device was used to complete the case.No 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 observed condition of the instrument.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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