Model Number IPN915269 |
Device Problem
Failure to Cut (2587)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device".No report of patient harm or injury.The patient status is reported as "unknown".
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Manufacturer Narrative
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Qn# (b)(4).Sample was received in its original packaging (sealed).No visual issues were observed.The punch was activated several times confirming that tip softly slides without getting stuck, testing conducted per procedure.A device history record review was performed, and no relevant findings were identified.Customer complaint cannot be confirmed as no quality issues were found during the evaluation of the representative sample.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during a renal transplant case performing an arterial anastomosis, "the punch got jammed.Scissors were used to cut around the punch to remove the device".No report of patient harm or injury.The patient status is reported as "unknown".
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Search Alerts/Recalls
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