The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(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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It was reported to boston scientific corporation that a captivator endoscopic mucosal resection device was used during a endoscopic mucosal resection (emr) procedure performed on (b)(6), 2022.When the device was opened the blue cap was dropped/lost so the blue cap was missing.The technician used their finger to complete suction loop instead.The device was successfully used in the antrum.When used in the fundus, the band captured muscularis due to too much suction and the band was deployed over the whole wall and was not realized until after it was cut, and a perforation occurred.The procedure was successfully completed with a non-bsc clip device.The patient outcome was reported to be fully recovered.There was no additional intervention required and the patient was not admitted to the hospital beyond standard of care.The patient condition at the conclusion of the procedure was reported to be fine.
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