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Model Number CUP CURETTE, NANO ARTHROSCOPY, 7CM |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
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 01/19/2024, it was reported by a sales representative via (b)(4) that there was a hole found in the sterile packaging of the nano arthroscopy cap curette, ar-1091cc-70-1.Found during an ankle arthroscopy procedure with no adverse effect to the patient.
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Search Alerts/Recalls
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