Catalog Number 544965 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2018 |
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 clip cannot be loaded into the applier properly, and it was easy to drop off the applier during the operation.The patient is fine.The applier was the newly purchased.
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Event Description
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It was reported that the clip cannot be loaded into the applier properly, and it was easy to drop off the applier during the operation.The patient is fine.The applier was the newly purchased.
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Manufacturer Narrative
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Qn#(b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of an 50 pc.Lot in october of 2017.The returned instrument was evaluated and found that the jaws are aligned properly with each other and the opened & closed jaw gaps meet print specifications.Further evaluation shows that this instrument is able to pick-up, retain, close and release multiple clips both with and without the use of silastic tubing as required of its function.We were unable to replicate the alleged issue therefore we are unable to validate the alleged complaint.
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Search Alerts/Recalls
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