As part of our investigation, olympus followed-up with the user facility to obtain additional information.The user facility further reported that the loop at the distal end of the device broke off and fell into the patient¿s prostatic urethra.The loop was retrieved and the device was removed from the patient without harm.In addition, the procedure was prolonged by 5 minutes.There was no sparking/arcing observed during procedure.There was no unexpected bleeding to the patient observed and the patient did not require a longer stay or additional treatment.Prior to procedure, the electrode was inspected with no irregularities noted.The generator settings were set to 200 cut, 80 coag; no error message was displayed.The oem conducted a review of the device history records (dhr) for the referenced device/lot number and there was no deviations or non-conformities noted during the manufacturing process.The referenced device will not be returned to olympus, therefore, the exact cause of the reported event cannot be confirmed.However, based on similar reported complaints, the reported event can potentially occur if the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated.As a preventive measure, the instruction manual contains several warning and caution statements in an effort to prevent damage to the electrode.Visually inspect the instrument prior to use.Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used.If the instrument is damaged or does not function properly, replace it.
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