The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 mdr will be filed.
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It was reported to boston scientific corporation that a trapezoid rx basket was used in the duodenal bulb during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2021.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a large stone.However, the handle broke and the tip failed to detach.The procedure was aborted and the patient underwent surgery on an unknown date to remove the basket and stone.
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