FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE-USE STAPLER
MDR report key: 1802580
·
Received August 11, 2010
Report
- Report Number
- 1219930-2010-00623
- Event Type
- Injury
- Date Received
- August 11, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 11, 2010
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K062850
- 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: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: AFTER THE ANASTOMOSIS WAS PERFORMED, BLEEDING WAS FOUND AND TREATMENT WAS DONE TO STOP THE BLEEDING. SIX DAYS AFTER THE SURGERY, THE PT CLAIMED OF STOMACH ACHE AND LEAKAGE WAS FOUND. THE PT IS CURRENTLY UNDER OBSERVATION. RE-OPERATION MAY BE DONE IN THE FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 31MM SINGLE-USE STAPLER | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |