Catalog Number 544240 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
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 a clip got broken at the hinge when it was ligated.Therefore, a new unit was opened instead.No clip fell/remained in the patient.
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Manufacturer Narrative
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(b)(4).Per dhr the product hemolok l clips 6/cart 84/box lot# 73f1600044 was manufactured on 06/03/2016 a total of (b)(4) pieces.Lot was released on 06/09/2016.Dhr investigation did not show issues related to complaint.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
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Event Description
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It was reported that a clip got broken at the hinge when it was ligated.Therefore, a new unit was opened instead.No clip fell/remained in the patient.
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Search Alerts/Recalls
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