Catalog Number 544965 |
Device Problems
Premature Activation (1484); Failure to Align (2522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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Because the jaw of the applier was misaligned clips fell off the applier easily.No clips fell into the patient.There was no patient injury.
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Manufacturer Narrative
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(b)(4).The dhr for the instrument in question, was reviewed and found complete without any irregularities.This instrument was manufactured at the tecomet, inc.Kenosha facility as part of a (b)(4).Lot in may of 2015.Since the instrument was not returned for evaluation we are unable to validate this complaint or determine root cause at this time.All instruments are thoroughly inspected and function tested at time of manufacture.No corrective action required at this time.
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Event Description
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Because the jaw of the applier was misaligned clips fell off the applier easily.No clips fell into the patient.There was no patient injury.
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Search Alerts/Recalls
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