Model Number M00562301 |
Device Problem
Failure to Cut (2587)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 10/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Block e1: the reported health care facility is (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.
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Event Description
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It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6), 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block e1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Imdrf patient code e2015 captures the reportable event of tissue damage.Block h11: blocks a2 (age at time of event) has been updated based on corrected information received on february 7, 2024.
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Event Description
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It was reported to boston scientific corporation that a captivator snare was used to remove a polyp around 0.8 cm in the ascending colon during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the polyp was not separated smoothly due to the large bluntness of the snare.The snare was securely attached to the active cord and no problems noted with the cautery pin.They made several cuts, and it successfully separated the polyp.However, the patient's wound area increased and caused a mucosal avulsion.Therefore, the physician used a hemostatic clip to close the wound.The procedure was completed with the original snare used.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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