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Model Number M00561223 |
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 05/31/2023 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician initially attempted to use a hot snare for a procedure, but it was unsuccessful in cutting through the tissue.They then tried using a different snare using cold polypectomy, but it also unsuccessful in cutting through the tissue.It was not reported what device was used to complete the procedure there were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a050702 captures the reportable event of loop cutting issue.
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Event Description
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It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician initially attempted to use a hot snare for a procedure, but it was unsuccessful in cutting through the tissue.They then tried using a different snare using cold polypectomy, but it also unsuccessful in cutting through the tissue.It was not reported what device was used to complete the procedure there were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a050702 captures the reportable event of loop cutting issue block h10: investigation results a captivator snare was received for analysis.Visual analysis of the returned device found no device problems.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended well.Continuity test was also performed and the device's electrical resistance was within specification.No other device 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.Most likely, procedural factors such as the handling of the device and the technique used by the physician during initial use, set-up, or shortly thereafter could have affected its condition and led to the reported event.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.
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Search Alerts/Recalls
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