Model Number M00562451 |
Device Problems
Failure to Cut (2587); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/07/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, the snare loop was knotted and deformed and could not remove the polyp.The procedure was completed with a similar captivator small hexagonal stiff snare.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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Block e1 (initial reporter facility name): (b)(6) hospital.Block h6: imdrf device code a050702 captures the reportable event of unable to cut.
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Event Description
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It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during an endoscopic mucosal resection procedure performed on (b)(6)2023.During the procedure, the snare loop was knotted and deformed and could not remove the polyp.The procedure was completed with a similar captivator small hexagonal stiff snare.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported to be stable.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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Block e1 (initial reporter facility name): tianjin medical university affiliated tumor hospital block h6: imdrf device code a050702 captures the reportable event of unable to cut block h10 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device found no device problems.Microscope analysis of the returned device found the loop was twisted.Functional analysis of the returned device found that the device was not able to extend completely.Electrical analysis was performed and the device's electrical resistance was within specification the reported event of "loop failure to cut" could not be confirmed, as it was not possible to evaluate the device's function during the specific procedure.Device analysis found that the loop did not extend and was twisted.It is most likely that during manipulation of the device an excess of force was applied to the device.Therefore, based on analysis of the returned device and all available information, the most probable cause for the reported event is cause not established.
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Search Alerts/Recalls
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