FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL STAPLER
MDR report key: 3902251
·
Received June 25, 2014
Report
- Report Number
- 1219930-2014-00468
- Event Type
- Injury
- Date Received
- June 25, 2014
- Date of Event
- April 8, 2014
- Report Date
- June 3, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GAG
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAPAROSCOPIC APPENDECTOMY. ACCORDING TO THE REPORTER: PATIENT IN THE OPERATING ROOM FOR LAPAROSCOPIC APPENDECTOMY. MD STATED THAT ENDO GIA STAPLER MISFIRED 3 TIMES. MD REPORTED THAT STAPLERS DID NOT CLOSE PROPERLY, RESULTING IN A HOLE IN THE PATIENT'S CECUM. MD STATED SHE HAD TO CONVERT FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE IN ORDER TO COMPLETE THE SURGERY DUE TO THE MISFIRING OF THE STAPLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370625 | EGIA ULTRA UNIVERSAL STAPLER | DISPOSABLE SURGICAL STAPLER | GAG | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |