FDA Adverse Event
Injury
Summary report: N
GIA UNIVERSAL
MDR report key: 2221569
·
Received August 18, 2011
Report
- Report Number
- 1219930-2011-00706
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 3, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE SURGEON TRIED TO RESECT SEVERAL TIMES, BUT THE HANDLE WAS VERY STIFF AND THE STAPLES WERE MALFORMED. ACCORDING TO THE SURGEON, THE GASTRIC WALL BECAME QUITE THICK DUE TO AN ULCER. THE PROCEDURE WAS CHANGED FROM A PARTIAL TO A TOTAL GASTRECTOMY. THERE WAS TISSUE DAMAGE AND UNANTICIPATED TISSUE LOSS. BLEEDING UNDER 200CC OCCURRED. THE PT IS UNDER POST OPERATIVE OBSERVATION. OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA UNIVERSAL | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | ENDO GIA ROTICULATOR 45-3.5 SULU: CATALOG#: 030455| (B)(4) |