FDA Adverse Event
Death
Summary report: N
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
MDR report key: 870410
·
Received June 25, 2007
Report
- Report Number
- 1527736-2007-04345
- Event Type
- Death
- Date Received
- June 25, 2007
- Date of Event
- June 1, 2007
- Report Date
- June 4, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A COLON RESECTION PROCEDURE, (ANASTOMOSIS PERFORMED AFTER A COLOSTOMY). THE STAPLES DID NOT HOLD ON THE TISSUES ON MORE THAN 1/2 SUTURE. THE SURGEON FINISHED THE PROCEDURE WITH MANUAL SUTURES. DURING THE NIGHT, THE PT HAD SOME PAINS AND A SEPTIC SHOCK AND HAD TO BE RE-OPERATED. THE PT WAS THEN URGENTLY OPERATED FOR A COLIC OBSTRUCTION/PERITONITIS (DISTENDED COLON/VERY THIN TISSUES). THE SURGEON REINFORCED THE STAPLE LINE WITH A MANUAL SUTURE. LATER THE PT WAS TRANSFERRED (CRITICAL STATE) TO AN INTENSIVE CARE OF A BIGGER HOSPITAL. THREE DAYS AFTER THE TRANSFER, THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT | GDW | ETHICON ENDO-SURGERY, INC. | NA | D4GP2Z |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |