FDA Adverse Event
Injury
Summary report: N
EEA 28MM SINGLE-USE STAPLER
MDR report key: 2922513
·
Received January 14, 2013
Report
- Report Number
- 2647580-2013-00022
- Event Type
- Injury
- Date Received
- January 14, 2013
- Report Date
- December 18, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GAG
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE SURGEON STATES THAT IN SEVERAL CASES, THERE WAS A CONTUSION OF TISSUE WITH THE EEA STAPLERS. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS UNANTICIPATED TISSUE LOSS. NO REINFORCEMENT MATERIAL WAS USED. NO ADD'L INFO REGARDING THIS REPORT WILL BE PROVIDED BY THE HOSP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20068 | EEA 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GAG | COVIDIEN, FORMERLY USSC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |