FDA Adverse Event
Malfunction
Summary report: N
EGIA 60 ARTICULATING MED/THICK SULU
MDR report key: 4871125
·
Received June 26, 2015
Report
- Report Number
- 1219930-2015-00497
- Event Type
- Malfunction
- Date Received
- June 26, 2015
- Date of Event
- May 28, 2015
- Report Date
- May 29, 2015
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LADG. CUSTOMER STATES: WHEN RESECTING GASTRIC BODY BY I-DRIVE, SURGEON PRESSED A GREEN BUTTON, AND CONFIRMED STATUS INDICATOR WAS FLASHING. THEN, HE/SHE PRESSED A BLUE BUTTON FOR FIRING, BUT THE DEVICE DID NOT FIRE AT ALL. REPLACED A RELOAD TO COMPLETE THE PROCEDURE. NOTHING FELL INTO THE CAVITY. NO BLEEDING. THE LAST PATIENT STATUS: GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 414998 | EGIA 60 ARTICULATING MED/THICK SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL A DIVISON | EGIA60AMT | N5B0945KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |