It was reported to boston scientific corporation that a lithovue flexscope was used during a cystoscopy, left ureteroscopy with laser lithotripsy and basket stone removal procedure performed on (b)(6) 2023.During the procedure, there was a left ureteral stent exchange, right ureteral stent removal and left retrograde pyelogram.While performing laser lithotripsy on the left ureter/kidney a thin metal like foreign body was found during the flushing process.It was reported the lithovue flexscope had the tip sheared off.In the physicians assessment the metal piece came from either the retrieval basket (unknown manufacturer) or the scope but did occur during the procedure.The instructions for use state the following: do not withdraw a laser fiber back into the ureteroscope while the laser is firing.Doing so may cause patient injury and/or scope damage.Inserting and removing an accessory and application of therapy note: if using a laser lithotripsy system, select a system which features an aiming beam with adjustable intensity or pulse option.Adjust aiming beam intensity or pulsation to allow clear live video image of the lithotripsy target.Do not actuate any accessory device, including laser lithotripsy devices, without a clear endoscopic live video image.If the laser aiming beam cannot be adjusted to provide a satisfactory image, abort the procedure.
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