Model Number 174006 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial reporter phone number: (b)(6).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.Post market vigilance (pmv) led an evaluation of one 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.A review of the device history record indicates the product was 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.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.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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According to the reporter: during a lap sacro-hysteropexy procedure, while tacking into the sacrum, the device jammed.A new device was opened to complete the case.There was no patient injury or medical or surgical intervention required.
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Manufacturer Narrative
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Corrected date manufacturer was notified of product problem.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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