This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number, device evaluation (photos provided) and investigation conclusion.Two photos of the referenced device were provided, the physical device was discarded and not returned for evaluation.Review of the photos provided by the customer, confirmed the reported failure.The probe was fractured at proximal end.The lot number could not be confirmed.Due to no device return, a root cause of the reported complaint could not be determined.Fracture of the probe is often a result of user mishandling during use.The probe must be kept concentric to the endoscope's instrument channel while active to prevent the introduction of unnecessary torque on the probe.As stated on the ifu (instruction for use) the user manual states" the probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance.Olympus will continue to monitor complaints for this device.
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