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Model Number 174006 |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/30/2018 |
Event Type
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 celioscopy intervention promontofixation procedure, there were no tacks that were fired normally from the device.When they placed the tackers, it resulted to hemorrhage and an unanticipated tissue loss.This resulted to an extended surgical time.A fixation with the surgical threads was done to complete the case.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.A visual inspection of the first product noted that a tack was protruding from the tip of the device.Additionally, the trigger was jammed.A visual inspection of the second product noted that the timing was disengaged.Additionally, the trigger was jammed.Functionally, the trigger of both instruments was actuated after disassembling the body from the tube.Tacks were jammed in both tubes and did not deploy due to the timing disruption.A review of the device history record indicates this 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 caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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