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, 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, right nephrostomy tube placement, right percutaneous nephrolithotomy, right renal access and dilation, right renal ultrasound with interpretation procedure performed on (b)(6) 2017.The patient experienced pneumothorax and medication was required.
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