(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 medwatch will be filed.
|
It was reported to boston scientific that a trapezoid rx lithotripter basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during preparation of the procedure, the wire of the handle was reported to be broken and not working.The procedure was completed with another of the same device.No patient complications were reported as a result of this event.
|