FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 3853524
·
Received May 30, 2014
Report
- Report Number
- 1219930-2014-00416
- Event Type
- Injury
- Date Received
- May 30, 2014
- Date of Event
- March 11, 2014
- Report Date
- May 7, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SUR
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: WEDGE RESECTION. ACCORDING TO THE REPORTER: THE RELOAD CUT BUT DIDN'T FIRE STAPLES. SEAMGUARD REINFORCEMENT MATERIAL WAS USED. THERE WAS TISSUE DAMAGE. ABOUT 250CC OF BLOOD WAS LOST. THE TISSUE WAS CLAMPED AND THEN SEWED TO CORRECT THE CONDITION. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. NO EFFECT TO THE PATIENT DUE TO THE DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318175 | ENDO GIA ROTICULATOR 60-3.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SUR | N3D0098LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ENDO GIA UNIVERSAL 12MM SINGLE USER INST, 030449| K900129 |