Catalog Number 544965 |
Device Problems
Leak/Splash (1354); Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/19/2019 |
Event Type
malfunction
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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 is misaligned and during surgery is not closing property, the clips are falling.
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Event Description
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It was reported that the applier is misaligned and during surgery is not closing property, the clips are falling.
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Manufacturer Narrative
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(b)(4).Per information provided from customer the dhr for the alleged device was reviewed and found completely without any irregularities.This instrument was produced as part of a 50 pc.Lot in november of 2017.This instrument has not been returned for review or evaluation therefore we are unable to determine what might have caused the jaws to be misaligned and also unable to validate the alleged complaint.All 50 instruments from this lot were 100% visually inspected and function tested prior to release to customer as this is a standardized procedure at this facility for this product line.
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Search Alerts/Recalls
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