FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 45-2.0 SULU
MDR report key: 2221615
·
Received August 19, 2011
Report
- Report Number
- 1219930-2011-00717
- Event Type
- Injury
- Date Received
- August 19, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 28, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SPLENECTOMY. ACCORDING TO THE REPORTER: THE PT WAS BLEEDING DUE TO NON-FORMATION OF STAPLES AFTER CUTTING DURING A SPLENECTOMY. MEDICAL INTERVENTION REQUIRED; SURGERY TIME WAS EXTENDED FOR MORE THAN 30 MINUTES; THE PT'S VITAL SIGNS ARE STABLE NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 45-2.0 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N7J233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |