Model Number 174006 |
Device Problems
Failure to Advance (2524); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2019 |
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, while fixating the tissue during a laparoscopic colpopexy, the device jammed.Another device was used 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 three device.Visual inspection of all three products noted the timing was disengaged and a tack was protruding.Additionally, the triggers of all three instruments were jammed.A functional evaluation found that the triggers of all three instruments were actuated after disassembling the body from the tube.Tacks were jammed in the tube and did not deploy due to the timing disruption.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 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.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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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