InjuryFBO
RICHARD WOLF PEDIATRIC RIGHT ANGLE SCOPE
Received Apr 7, 2020 · Event occurred Mar 20, 2020
Report MW5094069 · MDR key 9934164
Device
Product problems
- Material Fragmentation
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
DURING THE CYSTOSCOPY, IT WAS NOTED THAT THE OPEN ENDED 5 -FRENCH URETERAL CATHETER WAS BEING SHEARED BY THE SCOPE WHEN THE CATHETER WAS BEING WITHDRAWN. TWO SMALL SHAVINGS WERE IN THE BLADDER AS A RESULT OF THIS. THE FRAGMENTS FROM THE 5-FRENCH URETERAL CATHETER WERE IDENTIFIED AND REMOVED IN THEIR ENTIRETY. FDA SAFETY REPORT ID# (B)(4).