BOSTON SCIENTIFIC CORPORATION ORISE PROKNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Date 11/22/2021 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation during a retrospective series data collection that an orise proknife was used in the ascending colon during a colonic endoscopic submucosal dissection (esd) procedure performed on november 22, 2021.During the procedure, the patient experienced a perforation.An intraprocedural clip was placed to treat the perforation and complete the procedure.The patient received medication and was monitored.They were released later that day.The exact cause of the perforation is unknown, per the physician.The physician deemed the event had a possible relationship to the device and a causal relationship to the procedure.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(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 emdr will be filed.
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Search Alerts/Recalls
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