Insufficient information was provided by the user facility regarding the reported event.Multiple attempts were made to obtain additional information from the user facility but with no results.The scope was returned to olympus for evaluation.The evaluation could not confirm the reported event as the scope is in working condition and the reported scope was received intact with no significant damage.The scope was inspected and noted multiple non-olympus third party repairs on the insertion tube, eyepiece body, and bending section cover glue.The scope passed the leak test.A review of the reported scope¿s instrument history shows the scope was purchased on (b)(6) 2014 with no records of olympus service repairs.The olympus sales representative confirmed that the user facility had sent the reported scope to a non-olympus vendor for service/repair prior to returning to olympus.The cause of the reported event could not be confirmed.However, based on the device evaluation findings and no service history, improper maintenance cannot be ruled out as contributory factor.The instruction manual provides a prohibition of improper repair and modification which states, "olympus is not liable for any injury or damage that occurs as a result of repairs attempted by non-olympus personnel".The ifu also states, "this instrument does not contain any user-serviceable parts.Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result." if additional information from the user facility becomes available, this report will be supplemented accordingly.
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Olympus was informed that during the middle of a ureteroscopy with laser lithotripsy procedure, the doctor was utilizing a non-olympus access sheath and laser to break the exterior of the stone.As the doctor was making his way towards the middle of the stone, the doctor pulled the stone back then the scope became stuck at proximal location of the patient¿s ureter.The doctor cut the scope in half with sheers and left half of the scope in the patient.In addition, it was reported there was nothing unusual from the scope's behavior prior to the reported event.Resistance was only felt when withdrawing the scope.There was unexpected bleeding to the patient which was controlled via saline irrigation.The patient was given additional anesthesia.No additional information was provided.
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