Catalog Number 71114V |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/09/2019 |
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 fragmentation occurs when the clip is installed with an applier during use.
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Manufacturer Narrative
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(b)(4).Per the dhr, lot number 8859 of product 71114v vlock xlg clip 6/cart 14/box was manufactured on 05sep2018.A total of (b)(4) pieces were released.The lot was released on 25sep2018.Dhr investigation did not show issues related to complaint.The complaint sample was not returned for investigation.Therefore, the root cause cannot be established.
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Event Description
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It was reported that fragmentation occurs when the clip is installed with an applier during use.
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Manufacturer Narrative
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(b)(4).After an additional medical review, a determination was made to re-classify complaint 3011137372-2019-00270 as a malfunction.There was no serious injury.Complaint 3011137372-2019-00270 is a malfunction.
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Search Alerts/Recalls
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