FDA Adverse Event
Death
Summary report: N
PROXIMATE RELOADABLE LINEAR STAPLER
MDR report key: 1343180
·
Received March 12, 2009
Report
- Report Number
- 3005075853-2009-01506
- Event Type
- Death
- Date Received
- March 12, 2009
- Date of Event
- January 11, 2009
- Report Date
- February 17, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SUBTOTAL COLECTOMY (COMPLETE RESECTION OF RIGHT COLON AND TRANSVERSE + PORTION OF LEFT) PROCEDURE, THE ANASTOMOSIS WAS COMPLETED; EVERYTHING WAS VERIFIED IN TACT. THE SURGEON LATER FOUND AN ANASTOMOTIC LEAK ON THE ILEO-SIGMOIDAL ANASTOMOSIS IN EARLY 2009. THE PATIENT WAS REOPERATED THAT SAME DAY BECAUSE OF AN ABDOMINAL ABSCESS/LEAKAGE. THE PATIENT WAS GIVEN AN ILEOSTOMY; UNKNOWN WHEN IT WAS COMPLETED. THE PATIENT DIED TWO DAYS LATER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR STAPLER | GDW STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4M122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |