Catalog Number 001201 |
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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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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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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Event Description
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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) the customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.The device history review for the product horizon ti small red 6/cart 180/box lot# 73h2200617 investigation did not show issues related to the complaint.If the alleged defect samples become available later, this complaint will be updated accordingly.(associated reports 3003898360-2023-00341, 3003898360-2023-00339).
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Search Alerts/Recalls
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