FDA Adverse Event
Injury
Summary report: N
ENDO GIA II 60-3.5 SULU
MDR report key: 1902137
·
Received November 9, 2010
Report
- Report Number
- 2647580-2010-00896
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 25, 2010
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORT SENT TO FDA ON 11/11/2010. (B)(4).
Description of Event or Problem · 1
PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE STAPLER DID NOT FIRE NORMALLY ACROSS THE LESSER CURVE OF THE STOMACH. THE TISSUE WAS MILDLY THICK. THE STAPLER APPEARED TO FIRE NORMAL, BUT WHEN REMOVED, A LARGE BLEEDING HOLE IN THE REMNANT WAS SEEN. THEY WERE UNABLE TO CONTROL WITH RE-STAPLING USING A LARGER LOAD OR HAND SEWING. THIS REQUIRED RESECTION OF 1/3 OF THE STOMACH, A PROCEDURE WHICH WOULD USUALLY NOT HAVE BEEN DONE. PROCEDURE: LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA II 60-3.5 SULU | DISPOSABLE STAPLER | GDW | USSC PUERTO RICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Disability |