Model Number M00562671 |
Device Problems
Failure to Cut (2587); Defective Device (2588)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/06/2023 |
Event Type
malfunction
|
Event Description
|
Note: this report pertains to one of five sensation short throws used in the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, when the handle was tightened all the way, the polyp could not be removed.It was noted that the outer sheath at the front end of the device was found to be shorter when fully withdrawn when compared to the device used to complete the procedure.The procedure was completed with a similar sensation short throw.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Initial reporter facility: (b)(6).Initial reporter city: (b)(6).Imdrf device code a050702 captures the reportable event of loop unable to cut.
|
|
Event Description
|
Note: this report pertains to one of five sensation short throws used in the same procedure.It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an endoscopic mucosal resection procedure performed on (b)(6) 2023.During the procedure, when the handle was tightened all the way, the polyp could not be removed.It was noted that the outer sheath at the front end of the device was found to be shorter when fully withdrawn when compared to the device used to complete the procedure.The procedure was completed with a similar sensation short throw.
|
|
Manufacturer Narrative
|
Block e1: (b)(6).Block h6: imdrf device code a050702 captures the reportable event of loop unable to cut.Block e1 (initial reporter address 1) has been updated based on additional information received april 5, 2023.
|
|
Search Alerts/Recalls
|