FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL XL STAPLER
MDR report key: 2782052
·
Received September 17, 2012
Report
- Report Number
- 1219930-2012-00784
- Event Type
- Injury
- Date Received
- September 17, 2012
- Report Date
- September 14, 2012
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K080898
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE SURGEON USED 3 DUET 60MM 3.5MM RELOADS ACROSS THE POUCH. THE PT RETURNED TO THE HOSPITAL ON (B)(6) 2012 WITH A DIAPHRAGMATIC PERFORATION APPROXIMATELY 2-3CM FROM THE STOMACH POUCH. THE DIAPHRAGM PERFORATION WAS REPAIRED LAPAROSCOPICALLY. BOWEL THROUGH THE PERFORATION WAS NECROTIC AND HAD TO BE RESECTED IN AN OPEN PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EGIA ULTRA UNIVERSAL XL STAPLER | DISPOSABLE STAPLER | GDW | COVIDIEN, FORMERLY US SURGICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | DUET TRS 60 3.5MM ARTICULATING SULU, DUET6035A |