The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.Patient code (b)(4).Impact code (b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
|
It was reported to boston scientific corporation, through a post market clinical follow up (pmcf) of retrospective data collection, that a lithovue flexscope was used during a left ureteroscopy procedure performed on (b)(6) 2022.Physician performed cystoscopy on the patient and caused trauma at the level of the bladder in the neck and in the median lobe, resulting in minor bleeding in the patient prostate.Physician used bugbee monopolar to fulgurate.
|