Alleged failure: one out of 4 electrodes came off during use in the operating room the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be excessive force used when inserting or removing the probe, a probe inserted into an obstructed passageway, or any forceful impact to the tip of the probe with rigid objects.The probe is used as a tool for the mechanical displacement of tissue or bone, or to pry or scrub.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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