The device was not returned to olympus for evaluation.The cause of the event cannot be determined at this time.However, this type of guidewire damage is most likely related to the operator's technique.The instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire.¿inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc.Carefully and slowly withdraw the guidewire from the patient to avoid any damage.The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.¿.
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Olympus was informed that during an ureteroscopy procedure to crush/remove stones, the blue insulation of the guidewire broke off and fell into the patient.The patient¿s renal pelvis, ureter and bladder were thoroughly inspected but no fragment was found.It was believed that the device fragment had been flushed away.It was reported that the user felt resistance while attempting to insert the guidewire into the stent due its small diameter.The guidewire damage occurred while the user was withdrawing the stent and then observed the device fragment in the endoscopic view.The guidewire was replaced and the intended procedure was completed.There was no patient injury reported.
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