FDA Adverse Event
Injury
Summary report: N
DUET TRS 60 3.5MM ARTICULATING SULU
MDR report key: 2221282
·
Received August 17, 2011
Report
- Report Number
- 1219930-2011-00698
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 1, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K080898
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE CARTRIDGE DIDN'T CLOSE PROPERLY. THE STOMACH OPENED. THE DOCTOR USED ANOTHER CARTRIDGE MEDIALLY TO THE LAST ONE TO FIX THE ISSUE. THE PATIENT IS OK AFTER 3 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUET TRS 60 3.5MM ARTICULATING SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N0D0605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |