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Model Number DRV SFT,CANN,QC,T15 HEXALOBE |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported that during a procedure, the paint was flaking off of the following devices.The flakes were removed from the patient.No patient harm.Ar-8943-09, lot: 1391715, ar-8943-12, lot: 6791217, ar-8943-14, lot: 5262019.
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Manufacturer Narrative
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Complaint confirmed, the black and yellow coatings are chipped.The device does not appear damage or excessively worn.The cause of the event remains undetermined.
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Search Alerts/Recalls
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