This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.The product for this event was not returned for evaluation/inspection; therefore, this investigation was based solely upon the information provided by the customer.Additional information has been requested regarding this event.It is unclear if all pieces have been removed from the patient, nor is it known if an additional procedure would be required to remove any remaining fragments.However, there was no report of any patient harm.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to mechanical thermal influence (thermal mechanical overload), based upon the described damage pattern; also, improper handling, mechanical impact like a fall, shock, or similar stress were presumed as factors.Finally, war and tear was also presumed as a contributing cause of the event.However, these presumed causes cannot be further determined - it is unknown whether there was previous damage on the device or any damage on the ceramic insulating insert that may have been caused during last reprocessing or during last usage.The instructions for use (ifu) carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.Olympus will continue to monitor field performance for this device.H3 other text : device not returned.
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