The customer reported to olympus, the electrode roller ball becoming loose during what is presumed to be a urologic procedure.The roller ball was not recovered from the male patient.Additional information was requested; however, no further information was provided regarding the patient nor the event.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the reported failure was confirmed.The investigation findings are as follows: 1.The electrode wire (which leads the roller) was broken at both sides.2.Signs of thermal stress on the insulation sleeves.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the cause of the reported issue is likely due to wear and tear.During use, the distal end of the electrode wears off and can break, burn, or melt.Furthermore, both the roller and wire fell into the patient¿s body, and it is likely that the fragments were flushed out of the patient¿s body.However, details regarding flushing liquid was not provided.This supplemental report includes an update to h3 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
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