FDA Adverse Event
Injury
Summary report: N
EEA 25MM SINGLE-USE STAPLER
MDR report key: 4200781
·
Received October 24, 2014
Report
- Report Number
- 2647580-2014-00914
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- September 30, 2014
- Report Date
- September 30, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PROCEDURE TYPE: LOW ANTERIOR RESECTION.ACCORDING TO THE REPORTER:AFTER APPLYING THE FIRST DEVICE, THERE WAS AN ANASTOMOSIS LEAK. SHE USED A SECOND DEVICE BUT IT DID NOT CUT THE TISSUE PROPERLY. ANOTHER DEVICE WAS USED TO CUT THE TISSUE. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. AN ILEOSTOMY WAS PERFORMED. OPERATING TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO REINFORCEMENT MATERIAL USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680193 | EEA 25MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO INC | EEA25 | P3B0250X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Congenital Anomaly| O |