FDA Adverse Event
Injury
Summary report: N
GIA 80-3.8 SINGLE USE LOADING UNIT
MDR report key: 2232493
·
Received August 25, 2011
Report
- Report Number
- 2647580-2011-00579
- Event Type
- Injury
- Date Received
- August 25, 2011
- Report Date
- August 11, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GDW
- PMA / PMN Number
- K013860
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE PT PRESENTED A DUODENAL FISTULA POST SURGICAL OF TOTAL GASTRECTOMY, IN RE-INTERVENTION NOTED FILTRATION OF LINE OF MECHANICAL SUTURE LINEAR CUTTING MECHANICAL. IN THE POST OPERATORY SUSPECTED COMPLICATION TYPE INFECTION OR INTERNAL FISTULA IN LAPAROTOMY. A FISTULA OF 2MM OF DUODENAL STUMP IS FOUND, A HALF OF MECHANICAL SUTURE WITH SECONDARY PERITONITIS IN PARTICULAR MESOCOLIC COMPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GIA 80-3.8 SINGLE USE LOADING UNIT | DISPOSABLE SURGICAL STAPLER | GDW | USSC PUERTO RICO | P0K0768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| O| R |