FDA Adverse Event
Injury
Summary report: N
DUET TRS 60 4.8MM ARTICULATING SULU
MDR report key: 2140306
·
Received June 15, 2011
Report
- Report Number
- 1219930-2011-00498
- Event Type
- Injury
- Date Received
- June 15, 2011
- Report Date
- June 6, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K080898
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE FIRST TWO STAPLES DID NOT FORM PROPERLY RESULTING IN TEARING OF THE STAPLING AREA. THIS WAS A DANGEROUS SITUATION FOR THE PATIENT. THERE WAS BLEEDING IN EXCESS OF 250CC OPERATIVE TIME WAS DELAYED 1 HOUR. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUET TRS 60 4.8MM ARTICULATING SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O | EGIA ULTRA UNIVERSAL STAPLER| CATALOG #: EGIAUSTND, LOT: UNKNOWN |