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Model Number STOPCOCK,SINGLE,SPARE,FOR SYNERGY SHEATH |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/18/2021 |
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.
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Event Description
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It was reported that the surgeon fount something that may look like small red pieces of plastic in the knee joint during knee arthroscopy.They have examined everything, the only red is the red gasket of ar-3370-0001.The pieces were removed from patient.No harm or adverse event for patient, operator or third party was reported.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
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Manufacturer Narrative
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Complaint confirmed.The returned piece appears to be part of the o-ring, from the the ar-3370-0001 stopcock.Visual and function evaluation of the device could not be performed, since the device was not returned for further evaluation.The cause is undetermined.
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Search Alerts/Recalls
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