FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-2.5 SULU
MDR report key: 2140318
·
Received June 15, 2011
Report
- Report Number
- 1219930-2011-00504
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 8, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: WHEN THE STAPLE FIRED, IT WOULDN'T RELEASE WHEN PULLING BACK ON THE BLACK EARS. ANOTHER GUN WAS OPENED AND TWO 60 RELOADS WERE FIRED EITHER SIDE SO THE FAULTY STAPLER COULD BE RELEASED. AN ENDO CATCH BAG WAS USED TO RETRIEVE SPECIMEN. PATIENT STATUS: FINE. THE 100-150MLS BLOOD LOSS OCCURRED. OPERATIVE TIME WAS EXTENDED BETWEEN 45 MINS AND 1 HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-2.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N1B0467LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CATALOG #: 030449, LOT#: UNK| ENDO GIA UNIVERSAL: 12MM SINGLE USE INST |