The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.(b)(4).The complainant indicated that the device was 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 that a lithovue flexscope was used in a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue flexscope had poor vision and the light was flashing.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
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