MalfunctionGAS
PDS
Received Apr 3, 2013 · Event occurred Mar 20, 2013
Report 3080005 · MDR key 3080005
Device
Generic name
Suture, Surgical, Absorbable
Manufacturer
Ethicon, IncModel number
2-0 27" SH 26 MM 1/2C TAPERCatalog number
PDPB317H
Lot number
*
Product problems
- Break
- Detachment Of Device Component
Patient
55 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CLOSING LAYERS WHERE A COLOSTOMY HAD BEEN WHEN THE NEEDLE BROKE OFF IN THE PATIENT'S TISSUE. EXTENSIVE PALPATION DID NOT REVEAL NEEDLE PIECE. X-RAYS WERE DONE SHOWING LOCATION OF PIECE OF NEEDLE. PIECE OF NEEDLE WAS RETRIEVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COLOSTOMY TAKE-DOWN AND HERNIA REPAIR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.