The legal manufacturer performed a review of the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was not returned.Therefore, the root cause of the reported malfunction cannot be determined at this time.However, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
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The nurse at the user facility reported, during a therapeutic cystoscopy with laser lithotripsy of the bladder stone procedure, a piece of the resection sheath broke off into the bladder of the patient.The ellic evacuator was used to retrieve the broken pieces from the patient.It was flushed out with water and all pieces were accounted for.There was no delay in the procedure and the intended procedure was completed using the same device.The device was inspected prior to use.No deep impact was sustained to the device.There was no patient injury associated with this event.
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The customer returned the subject device to the service center.The evaluation confirmed a portion of the black colored insulation tip was broken off and missing.The device was repaired to specification and returned to the customer.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacturer determined the damage to the insulation insert was most likely caused by thermo-mechanical fatigue / wear and tear.Another possible cause is improper handling by the customer, more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.It is unknown if there was pre-existing damage to the insulation insert or if it was already worn.Furthermore, it cannot be determined if the damage was caused during the last reprocessing of the instrument or during its last use in a procedure.In this case, the fragment was successfully removed from the patient's bladder.Lost fragments of the ceramic insulation insert can be localized using a suitable x-ray procedure or computed tomography.Olympus will continue to monitor complaints for this device.
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