Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 11/16/2021 |
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 distal esophagus/gastroesophageal (ge) junction during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.An i knife and nanoknife 165 (non-bsc devices) were also used in the procedure.An esophageal hemorrhage occurred 11-12 days post-op from a vessel under the procedure site.The physician deemed the event to be not related to the device and probably related to the procedure.The patient was hospitalized and underwent an endoscopic reintervention for the esophageal hemorrhage.The patient was discharged three days later on (b)(6) 2021.
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Manufacturer Narrative
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The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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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Manufacturer Narrative
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Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: corrections: h6 (impact code).
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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 distal esophagus/gastroesophageal (ge) junction during an endoscopic submucosal dissection (esd) procedure performed on (b)(6), 2021.An i knife and nanoknife 165 (non-bsc devices) were also used in the procedure.An esophageal hemorrhage occurred 11-12 days post-op from a vessel under the procedure site.The physician deemed the event to be not related to the device and probably related to the procedure.The patient was hospitalized and underwent an endoscopic reintervention for the esophageal hemorrhage.The patient was discharged three days later on (b)(6), 2021.
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Search Alerts/Recalls
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