MalfunctionFEC
CIRCON ACMI
Received Mar 13, 1998 · Event occurred Mar 9, 1998
Report MW1013210 · MDR key 157645
Device
Generic name
Cyst Obturator
Manufacturer
Circon AcmiModel number
ETOR-24 TIMBERLAKE OBTURATORCatalog number
*
Lot number
*
Product problems
- Loose
- Cut In Material
Patient
33 YR
- Laceration(s)
Narrative
Description of Event or Problem
LOOSE PIN IN OBTURATOR TIP, PROTRUDING, AND CAUSED LACERATION OF URETHRA. PROGNOSIS (LONG TERM) UNK AT THIS TIME.