(b)(4).According to the complainant, the suspect devices has been disposed, and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
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Note: this report pertains to one of five devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-03955, 3005099803-2020-03957, 3005099803-2020-03959 and 3005099803-2020-03960 for the associated device information.It was reported to boston scientific corporation that a total of five sensation medium oval flexible snares were used to remove polyps in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, when the snare was used to cut through the target polyp, the snare got caught on the tissue.There was no resistance and the snare would not cut through.There were no signs of blanching (tissue turning white).During troubleshooting, the cautery was reattached and the snare was securely attached to the active cord.Reportedly, there was no visible issue noted with the cautery pin and no other issues were noted with the five devices.The procedure was completed with another sensation snare.There was no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
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