FDA Adverse Event
Malfunction
Summary report: N
EGIA 45 ARTICULATING VAS/MED SULU
MDR report key: 4080934
·
Received July 9, 2014
Report
- Report Number
- 1219930-2014-00516
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 19, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: RELOAD WOULD OPEN AND CLOSE, ARTICULATE AND ROTATE; HOWEVER, WOULD NOT GO INTO FIRING MODE ON IDRIVE ULTRA STAPLER. REPLACED WITH NEW RELOAD AND FINISHED CASE WITHOUT ISSUE. CORRECTIVE ACTION TAKEN RELEVANT TO THE CARE OF THE PT: USED ANOTHER RELOAD AND FINISHED CASE. PT OUTCOME: CASE COMPLETED. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400694 | EGIA 45 ARTICULATING VAS/MED SULU | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY US SURGICAL | N4D0416KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IDRVULTRA1, IDRIVE ULTRA POWERED HANDLE 1,| K121510 |