FDA Adverse Event
Injury
Summary report: N
EEA XL 25MM SINGLE-USE STAPLER
MDR report key: 2061219
·
Received April 5, 2011
Report
- Report Number
- 1219930-2011-00268
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- March 22, 2011
- Report Date
- March 23, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPICALLY ASSISTED TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: THE ANVIL WAS INSERTED ORALLY, BUT IT COULD NOT BE CONNECTED TO THE DEVICE. CONVERTED TO OPEN SURGERY AND THEN THE ANVIL HEAD OF THE (B)(4) WAS USED FOR THE ANASTOMOSIS. OOZING WAS UNDER 200CC. NOTHING FELL INTO THE PATIENT CAVITY. THE OPERATIVE TIME WAS EXTENDED MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA XL 25MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | U7L44 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | DST SERIES EEA ORVIL 25MM DEVICE: (B)(4)| LOT NUMBER N0L0628UL, MANUFACTURED:11/01/2010| EXPIRATION DATE:11/30/2015 |