FDA Adverse Event
Injury
Summary report: N
EEA 28MM SINGLE-USE STAPLER
MDR report key: 2221531
·
Received August 17, 2011
Report
- Report Number
- 1219930-2011-00700
- Event Type
- Injury
- Date Received
- August 17, 2011
- Report Date
- August 4, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DEFECTIVE IS ALL THAT COULD BE REPORTED. COMPLETION OF THE CASE WAS NOT KNOWN. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO REPORT OF TISSUE DAMAGE, NO REPORT OF UNANTICIPATED TISSUE LOSS OR IMPROPER STAPLE FORMATION, NOR ANY REPORT OF BLEEDING IN EXCESS OF 250CC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N0C0192UH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |