Model Number IPN914937 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/17/2023 |
Event Type
Injury
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Event Description
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Reported issue: reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
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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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Manufacturer Narrative
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(b)(4).At this time, the root cause is still unknown as the complaint investigation is pending completion from supplier, tecomet.The sample has not be returned to the supplier at time of this report.Per the complainant they are "taking clip appliers that are not functioning properly out of circulation." teleflex will reevaluate if a root cause is determined by supplier.As of now there is no root cause and no increase in risk level from hazard review estimate.No further action required.
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Event Description
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Reported issue: reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample has yet been received at tecomet facility for evaluation.Per customer provided information we are unable to perform a thorough device history review (dhr) for the alleged defective instrument since lot information has not been provided.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.All instruments of this type are 100% function tested and visually inspected prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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Reported issue: reported issue: multiple cardiac post-op bleeds as a result of ligating clips coming off arterial branches.The patient's condition is unknown.
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Search Alerts/Recalls
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