Model Number M00560311 |
Device Problem
Failure to Cut (2587)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/27/2023 |
Event Type
malfunction
|
Event Description
|
It was reported to boston scientific corporation that a sensation medium oval med stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare was unable to cut through the polyp.The procedure was completed with a similar sensation medium oval med stiff snare.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a050702 captures the reportable event of unable to cut.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a050702 captures the reportable event of unable to cut block h10 investigation results: one sensation snare was received for analysis.Visual and electrical analysis of the returned device found no device problems.No other problems were noted.The reported events of "loop failure to cut" could not be confirmed since could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Device analysis found no problems with the device during visual and electrical test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected.This code was selected since the reported event could not be confirmed.
|
|
Event Description
|
It was reported to boston scientific corporation that a sensation medium oval med stiff snare was used during a colonoscopy procedure performed on (b)(6), 2023.During the procedure, the snare was unable to cut through the polyp.The procedure was completed with a similar sensation medium oval med stiff snare.There were no patient complications reported as a result of this event.
|
|
Search Alerts/Recalls
|