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 07/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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 procedure, the device was fired for ten times, but the handle jammed and the surgeon was not able to fire the tacks.They used another device to resolved the issue and complete the case.The patient was alive with no injury.
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Manufacturer Narrative
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Section evaluation summary: post market vigilance (pmv) led an evaluation of one device.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.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.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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Event Description
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According to the reporter: as per the additional information received, during a laparoscopic ventral hernia repair, while firing into muscle tissue.
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Search Alerts/Recalls
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