FDA Adverse Event
Malfunction
Summary report: N
EGIA 60 ARTICULATING VAS/MED SULU
MDR report key: 3924681
·
Received June 25, 2014
Report
- Report Number
- 1219930-2014-00472
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 5, 2014
- Manufacturer
- COVIDIEN, FORMERLY U.S. SUR
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAPAROSCOPIC ROUX-EN-Y ; ACCORDING TO THE REPORTER: THE RELOAD WAS LOADED ONTO THE ADAPTER, CYCLED THROUGH, AND ENTERED INTO THE PATIENT LAPAROSCOPICALLY. WHEN THE SURGEON CLAMPED THE RELOAD SHUT, THE GREEN RELOAD INDICATOR LIGHT WAS BLINKING AS IF THE RELOAD WAS NOT RECOGNIZED. HE REMOVED THE INSTRUMENT, AND COMPLETED THE CASE WITH THE SAME RELOAD ON A MANUAL STAPLER. REINFORCEMENT MATERIAL (GORE) WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369675 | EGIA 60 ARTICULATING VAS/MED SULU | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY U.S. SUR | N4C1374KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SERIAL NUMBER (B)(4),| MFG DATE 07/01/2013,| K121510| MFG DATE 07/01/2013,| LOT NUMBER N3G0351UX,| K121510| SERIAL NUMBER (B)(4),| IDRVULTRA1,| EGIAADAPT,| LOT NUMBER N3G0449UX,| ENDO GIA ADAPTER STANDARD, |