(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.
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Note: this manufacturer report pertains to one of three devices supposed to be used in the same procedure.Refer to the associated manufacturer report numbers 3005099803-2018-01256 and 3005099803-2018-01257 for the other associated device information.It was reported to boston scientific corporation on april 04, 2018 that three lithoclast ultrasound probes were opened to be used for a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2018.According to the complainant, during preparation and outside the patient, the packaging including the sterile pouch was noted to be crumpled on all three lithoclast ultrasound probes.The plastic packaging was also bent up.The procedure was completed with another lithoclast ultrasound probe.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 fine.
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