MalfunctionFDX
BIOPSY BRUSH
Received Apr 29, 2021 · Event occurred Apr 16, 2021
Report MW5101086 · MDR key 11752250
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Cook IncorporatedModel number
040310Catalog number
G14919
Lot number
13597835
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
BIOPSY BRUSH PASSED THROUGH SCOPE. WHEN REMOVED FROM SCOPE, IT WAS NOTED THAT NO BRUSH WAS ATTACHED. A SECOND BRUSH WAS OPENED AND USED. INTRA-OP X-RAYS OBTAINED TO VERIFY BRUSH DID NOT BREAK OFF IN PATIENT. STORZ REP WAS MADE AWARE TO EVALUATE SCOPE. FDA SAFETY REPORT ID# (B)(4).