Date of event: the exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The initial reporter address is (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during a polypectomy procedure performed on an unknown date.According to the complainant, during the procedure, the snare would not cut the target polyp.The physician troubleshoot the device by opening and closing it again.However, the issue was not resolved.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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