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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(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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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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(b)(4).The dhr for the returned instrument was evaluated and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha facility as part of a 50 pc.Lot in (b)(6) 2018.The returned instrument was evaluated and found that the jaw to handle mechanism is binding badly thus we are able to validate this complaint.Further evaluation after the tube assembly was removed from the knob assembly showed that the drive rod was twisted/bent and damaged at the jaw end of the applier.All 50 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 to be bent/damaged but mishandling of this instrument at the end user's facility is suspected.
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Search Alerts/Recalls
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