FDA Adverse Event
Injury
Summary report: N
ENDO GIA UNIVERSAL XL
MDR report key: 2140300
·
Received June 15, 2011
Report
- Report Number
- 1219930-2011-00497
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- May 25, 2011
- Report Date
- June 3, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: ON THE SECOND FIRING THE DEVICE ONLY DEPLOYED HALF THE STAPLE LINE AND MADE A CRUNCH SOUND. IT WOULD NOT FINISH FIRING IT WAS AS IF IT WAS A PARTIAL FIRING BUT IT GOT STUCK AT THE MIDPOINT. OPERATIVE TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. UNANTICIPATED TISSUE LOSS OCCURRED. THE INCISION WAS EXTENDED BY MORE THAN 1 INCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA UNIVERSAL XL | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N9A162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| S |