Catalog Number 544990 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/29/2017 |
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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The applier did not release a clip during ligation of renal artery.The clip was finally release and the therapy was finished.The clip did not fall in the patient's body or out of the body.No health damage was observed.
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Manufacturer Narrative
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(b)(4).The dhr for the instrument in question was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a 50pc.Lot in september of 2015.Since the instrument was not returned for evaluation we are unable to validate this complaint or determine root cause.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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The applier did not release a clip during ligation of renal artery.The clip was finally release and the therapy was finished.The clip did not fall in the patient's body or out of the body.No health damage was observed.
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Search Alerts/Recalls
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