Model Number M00561231 |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block e1: (b)(6) university.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 15mm captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, the snare was unable to resect a 6mm polyp.The procedure was completed with a similar 15mm captivator ii round stiff snare.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, the snare was unable to resect a 6mm polyp.The procedure was completed with a similar 15mm captivator ii round stiff snare.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block e1: (initial reporter facility name) (b)(6) university.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, functional and electrical analysis of the returned device found no device problems.No other problems were noted.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to the anatomical/procedural factors encountered during the procedure.Device analysis found no problems with the device during visual, functional, and continuity test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected since the reported event could not be confirmed.
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Search Alerts/Recalls
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