FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3/5 SULU
MDR report key: 3818074
·
Received May 12, 2014
Report
- Report Number
- 1219930-2014-00361
- Event Type
- Injury
- Date Received
- May 12, 2014
- Date of Event
- March 10, 2014
- Report Date
- April 17, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING SURGERY, THE STAPLER WAS DIFFICULT TO SHUT AND THE STAPLING AND CUTTING WERE OF POOR QUALITY. THE SUTURE WAS NOT SUCCESSFUL AND THE SURGEON ALSO NOTICED A DEFORMATION OF THE JAWS. HE HAD TO CONVERT THE INTERVENTION TO AN OPEN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283340 | ENDO GIA ROTICULATOR 60-3/5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3K1985LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |