The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation on (b)(6) 2018 that a lithovue scope was used during a ureteroscopy procedure in the ureter and kidney performed on (b)(6) according to the complainant, during the procedure and inside the patient, the shaft of the lithovue scope bent over onto itself and locked.Reportedly, the scope was not constrained in the patient's anatomy and there was no more than normal pressure applied when maneuvering the scope.The shaft could not be straighten when articulating.A super stiff wire was used to manipulate the shaft and the scope was removed from the patient.When the scope was outside the patient, the deflection mechanism works fine.The procedure was completed with another lithovue scope.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
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