MalfunctionFHO
INSUFFLATION/ACCESS NEEDLE 14 GAUGE
Received Aug 1, 2006 · Event occurred Jul 13, 2006
Report 2647580-2006-00328 · MDR key 760710
Device
Generic name
Disposable Surgical Access Device
Manufacturer
Ponce - UssModel number
*Catalog number
S100000
Lot number
UNK
Product problems
- Difficult To Position
- Replace
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PROCEDURE: LAP CHOLECYSTECTOMY. REPORTEDLY, AFTER INSERTING THE ACCESS NEEDLE INTO THE CAVITY, THE NEEDLE COVER COULD NOT RETURN TO THE PROPER POSITION. THE BLADE REMAINED EXPOSED. ANOTHER DEVICE WAS USED.