The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The lot number does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined, however, it was reported that the device was not used past expiry date.(b)(6).The complainant indicated that the device is implanted 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 medwatch will be filed.
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It was reported to boston scientific corporation that an upsylon¿ y-mesh was implanted during a robotic sacroculpopexy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the mesh torn.According to the operating physician, the mesh was probably cut by the grasper with a blade she was using.Reportedly, it is the same grasper they routinely use.However, during this procedure, the mesh had a lot of tearing on the side with the grasper.The physician assistant in the procedure reported that the operating physician probably cut a tiny piece of the mesh with the grasper, and then when they pulled on it to tension the mesh to the sacral promontory, it tore further.Subsequently, the they sutured the torn mesh together to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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