Model Number SYNERGY RESECTION SHAVER CONSOLE |
Device Problems
Explosion (4006); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
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 10/5/2023, it was reported by a facility representative via sems-06050473 that an ar-8305 synergy resection shaver console made a loud boom sound and then the device blew up.The patient was not affected.This was discovered during an unspecified procedure, with no reported patient harm.Additional information requested.
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Event Description
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On 10/5/2023, it was reported by a facility representative via (b)(4) that an ar-8305 synergy resection shaver console made a loud boom sound and then the device blew up.The patient was not affected.This was discovered during an unspecified procedure, with no reported patient harm.Additional information received on 11/16/2023: it was stated via e-mail that the ar-8305 synergy resection shaver console stopped working (turned off) and could not power back up.The console did not "blow up.".
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Manufacturer Narrative
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Additional info: b5 corrected data: h2 reportable event to 'na', h6 fields updated.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
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Search Alerts/Recalls
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