MalfunctionFHO
INSUFFLATION/ACCESS NEEDLE 14 GAUGE
Received May 30, 2006 · Event occurred May 8, 2006
Report 2647580-2006-00235 · MDR key 721463
Device
Generic name
Disposable Surgical Access Device
Manufacturer
Ponce - UssModel number
*Catalog number
S100000
Lot number
P6A753
Product problems
- Failure to Advance
Patient
UNKNOWN
- Bleeding
- Tissue Damage
- Surgical procedure, additional
Narrative
Description of Event or Problem
PROCEDURE: OOPHEROCYSTECTOMY. WHEN THE PACKAGE WAS OPENED THE BLUNT STYLET WAS OBSERVED TO BE RETRACTED AND THE NEEDLE WAS EXPOSED. THE SURGEON PROCEEDED TO INSERT IT INTO THE CAVITY BUT THE STYLET WOULD NOT ADVANCE. HOWEVER, THE CAVITY HAD BEEN PENETRATED WHICH CAUSE A SMALL AMOUTN OF TISSUE DAMAGE WHICH RESULTED IN BLEEDING OF LESS THAN 100CC. THE SURGEON USED ELECTROCAUTERY TO STOP THE BLEEDING.