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Model Number REELPASS SUTR LASSO,45° CRV RT |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2024 |
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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On 1/29/2024, it was reported by a sales representative via (b)(4) that an ar-6069-45r reelpass suture lasso malfunctioned.When the surgeon advanced the wheels to deploy the microfilament, only some would come out and then it would stop.This was discovered during a rotator cuff case.The case was completed with another ar-6069-45r with no patient harm.
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Search Alerts/Recalls
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