Catalog Number 544995 |
Device Problem
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 04/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (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 two weck 10mm hem-o-loks have failed during cases.In both cases once the clip was locked; could not open.
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Manufacturer Narrative
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Qn#(b)(4).The dhr for the returned device was reviewed and found completely without any irregularities.This instrument was produced at the tecomet inc.Kenosha facility as part of a (b)(4) pc.Lot in (b)(6)2018.Evaluation of the returned device showed that the handle mechanism was binding and that when it is actuated the jaws do not move therefore , we are able to validate this complaint.Further evaluation after the tube assembly was removed from the knob assembly shows that the end of the drive rod that actuates the jaws when the handle is actuated is broken off.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to customer.We are unable to determine what caused the drive rod end to be broken at the jaw end but mishandling at the end user's facility is suspected.
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Event Description
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It was reported that two weck 10mm hem-o-loks have failed during cases.In both cases once the clip was locked; could not open.
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Search Alerts/Recalls
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