FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE-USE STAPLER
MDR report key: 3940720
·
Received July 2, 2014
Report
- Report Number
- 2647580-2014-00485
- Event Type
- Injury
- Date Received
- July 2, 2014
- Date of Event
- June 7, 2014
- Report Date
- June 17, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
- Product Code
- GAG
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE STAPLES DID NOT CLOSE. THE STAPLES REMAINED IN THE ANVIL AND JUST FELL OUT IN THEIR ORIGINAL UNFORMED STATE AFTER BEING FIRED. THE TISSUE WAS CUT BUT NO STAPLE LINE WAS PLACED. THE PATIENT ENDURED TWICE THE ANESTHESIA TIME AND 4 EXTRA STAPLERS AND SUPPLIES WERE OPENED. THERE WAS BLEEDING REPORTED IN EXCESS OF 500CC. PRESENCE OF UNANTICIPATED TISSUE LOSS IS UNKNOWN DUE TO POTENTIAL INFECTION RISE IN THE FUTURE. THE CASE WAS EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385314 | EEA 31MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GAG | COVIDIEN, FORMERLY USSC PUERTO RICO, INC. | P3M0313KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |