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Model Number 174006 |
Device Problems
Failure To Adhere Or Bond (1031); Failure to Advance (2524); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/12/2018 |
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 tacking the mesh in coopers ligament during a totally extra peritoneal laparoscopic inguinal hernia procedure, the device was cracking and no tacks were able to be fired normally from the device.They fired 3 tacks and all the tacks just went trough the mesh without fixating the mesh.They opened a new device which worked well in order to complete the case.There was no patient injury.
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Manufacturer Narrative
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Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Video inspection noted mesh and there was a clicking noise in the background.The device was not visible in the video.Visual inspection of the product noted the timing was disengaged.Additionally, the trigger was jammed.Functionally, the trigger of the instrument was actuated after disassembling the body from the tube.Tacks were jammed in the tube and did not deploy due to the timing disruption.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.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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