FDA Adverse Event
Injury
Summary report: N
UNKNOWN ENDO GIA SULU
MDR report key: 2140268
·
Received June 15, 2011
Report
- Report Number
- 1219930-2011-00508
- Event Type
- Injury
- Date Received
- June 15, 2011
- Report Date
- May 24, 2011
- Manufacturer
- UNITED STATES SURGICAL A
- 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
ACCORDING TO THE STUDY: THE GIA STAPLER WAS USED TO DIVIDE THE RENAL VEIN. THE DONOR PATIENT UNDERWENT CONVERSATION FROM HLDN INTO OPEN DONOR NEPHRECTOMY DUE TO ACTIVE BLEEDING FROM THE RENAL STUMP AFTER THE GRAFT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ENDO GIA SULU | DISPOSABLE STAPLER | GDW | UNITED STATES SURGICAL A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |