Model Number IPN915191 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that the applier was sent to our technical specialist as the user felt that the clip did not easily leave the applier during a laparoscopic cholecystectomy.No clip fell in the patient.On follow-up, the specialist confirmed that the applier could not be assembled properly; the inner shaft got detached after assembly.
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the applier was sent to our technical specialist as the user felt that the clip did not easily leave the applier during a laparoscopic cholecystectomy.No clip fell in the patient.On follow-up, the specialist confirmed that the applier could not be assembled properly; the inner shaft got detached after assembly.
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Manufacturer Narrative
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(b)(4).During visual and functional examination, we found the following: pull rod bent/deformed.Due to deformation of the pull rod, the applier cannot be assembled properly.The locking of the shaft and the insert is worn out.The instrument w/ lot r0 - 01 was shipped to tfx with invoice #2207355 of 09/06/20.Upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.100% functional test at final inspection found good.The root cause is too much force to the handle during use, worn out locking.At k & w, no further measures will be initiated; this complaint is being rejected by us.
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Search Alerts/Recalls
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