Catalog Number 0504880314 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the tip of the electrode broke off inside the patient.All broken pieces were retrieved successfully.
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Manufacturer Narrative
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Alleged failure: it was reported that the cutting loop fell off tip.It was reported that all pieces were removed from patient.The failure identified in the investigation is consistent with the complaint record.The probable root cause could be user excessive force.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacture date is not known.
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Event Description
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It was reported that the tip of the electrode broke off inside the patient.All broken pieces were retrieved successfully.
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Search Alerts/Recalls
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