FDA Adverse Event
Injury
Summary report: N
33MM HEMORRHOID STAPLER 3.5MM STAPLES
MDR report key: 2250069
·
Received September 9, 2011
Report
- Report Number
- 1219930-2011-00777
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 19, 2011
- Report Date
- August 25, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083781
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: INCOMPLETE STAPLE LINE OCCURRED. SUTURES WERE PLACED TO CORRECT THE ISSUE. OPERATIVE TIME WAS EXTENDED BY MORE THAN 30 MINUTES AS A RESULT OF EVENT. STAPLES WERE REPORTED TO BE MALFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 33MM HEMORRHOID STAPLER 3.5MM STAPLES | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |