ARTHREX, INC. APOLLORF¿ XL90, ASPIRATING ABLATOR 90°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number APOLLORF¿ XL90, ASPIRATING ABLATOR 90° |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2022 |
Event Type
malfunction
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Event Description
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On (b)(6) 2022 it was reported by a sales representative via sems that an ar-9821 apollo rf 90` ablator had an issue during a case.The very end of the part just blew off.There was no harm to the patient.
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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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Search Alerts/Recalls
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