FDA Adverse Event
Injury
Summary report: N
ENDO GIA II 60-3.5 SULU
MDR report key: 2250079
·
Received September 9, 2011
Report
- Report Number
- 2647580-2011-00611
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 19, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: BARIATRIC PROCEDURE. ACCORDING TO THE REPORTER: DURING A SURGICAL PROCEDURE FOR OBESITY, FOUR PIECES OF THE SAME BATCH DID NOT STAPLE, CAUSING LEAKAGE AND BLEEDING. THE DOCTOR HAD TO MAKE AN OPENING IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA II 60-3.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | USSC PUERTO RICO | P1B0834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |