The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis and if there is any further relevant information from that review, a supplemental medwatch will be filed.
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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 cystourethroscopy with right ureteral stent placement, cystourethroscopy with right ureteral stent removal, left ureteroscopy with laser lithotripsy, right infundibulotomy, right renal ultrasound with interpretation, right retrograde pyelogram with fluoroscopic interpretation, right ureteroscopy procedure performed on (b)(6) 2021.The patient experienced an inflammation and urinary tract infection.The patient was given medication.
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