Catalog Number 533166 |
Device Problems
Difficult To Position (1467); Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2017 |
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 is unable to mount the hemoclip.Once mounted, closing the applier, the hemoclip remains adherent to the device.
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Manufacturer Narrative
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(b)(4).The dhr for the returned instrument was reviewed and found complete without any irregularities, this instrument was produced at the (b)(6) as part of a 25 pc.Lot in (b)(6) of 2016.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 is unable to mount the hemoclip.Once mounted, closing the applier, the hemoclip remains adherent to the device.
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Search Alerts/Recalls
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