Model Number 174006 |
Device Problems
Mechanical Jam (2983); Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This event was originally reported on a quarterly summary report and is being resubmitted per fda request.User facility listed in (b)(4), (b)(6).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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Event Description
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During a lap inguinal hernia repair, while tacking the mesh to muscle tissue, the surgeon was using the protack to tack the mesh by squeezing the trigger and firing tacks and it was working just fine.All of a sudden, the handle jammed and he was unable to fire any more tacks.None of the tacks were able to be fired normally from the device.No injury as a result of the event.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of the device.The event report alleges the product was used in a surgical procedure.The visual inspection of the returned product noted the unit had disrupted timing.The handle was unable to be actuated.The shaft was disassembled from the handle and the handle was able to cycle properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures; therefore, a device history record will not be performed.Replication of the reported condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.No enhancements or improvements were generated for the reported condition.Based on the evidence available the reported condition was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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