Model Number FASTPASS SCORPION-MULTIFIRE |
Device Problems
Break (1069); Entrapment of Device (1212); Device Fell (4014)
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Patient Problems
Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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Event Date 10/29/2021 |
Event Type
malfunction
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Event Description
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On (b)(6) 2021, it was reported by a facility representative via sems that an ar-13997mf fastpass scorpion broke.This occurred during a procedure, and the broken fragment was lost in 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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