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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(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.
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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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(b)(4).One representative sample of catalog number dp-36k batch 74f2300380 was received for evaluation.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.The product ifu contain some warnings about the care and proper use of product.Like "remove the excised tissue before additional openings are created.Excessive cleaning of the punch in between cuts is not necessary.Failure to remove excised tissue from the punch or excessive cleaning may cause punch jamming or incomplete cuts." 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.
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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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