MalfunctionFEC
USA ELITE CYSTOURETHROSCOPE STANDARD OBTURATOR
Received Jun 28, 2001 · Event occurred Mar 28, 2001
Report 1519132-2001-00052 · MDR key 341430
Device
Product problems
- Detachment Of Device Component
- Material Disintegration
- Tip breakage
Patient
NO INFO
- Foreign body, removal of
- Therapy/non-surgical treatment, additional
- Surgical procedure, additional
Narrative
Description of Event or Problem
REPORTEDLY, DURING A TVT (TRANSVAGINAL TAPE), THE TIP OF THE OBTURATOR FELL OFF INTO THE BLADDER AND DISINTEGRATED INTO SEVERAL PIECES. SOME OF THE FRAGMENTS WERE REMOVED "USING A SECOND CYSTOSCOPE." AND THE REMAINING FRAGMENTS (TOO SMALL TO BE PICKED OUT WITH A CLIP) WERE REMOVED BY CHECKING AND FILTERING THE PT'S URINE.
Remedial action
- Replace