FDA Adverse Event
Malfunction
Summary report: N
IDRIVE ULTRA POWERED HANDLE 1
MDR report key: 3844845
·
Received March 12, 2014
Report
- Report Number
- 1219930-2014-00189
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 20, 2014
- Report Date
- February 20, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K121510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: CUSTOMER INFORMS THAT ONCE THE DEVICE WAS PROPERLY ASSEMBLED AND ATTACHED THE EGIA60AMT SULU THE SURGEON INSERTED THE IDRIVE THROUGH THE TROCAR AND STARTED PLACING THE TISSUE BETWEEN THE JAWS. AT THAT VERY MOMENT THE SULU STARTED ARTICULATING WITHOUT CONTROL. THE SURGEON DECIDED TO CHANGE THE SULU AND ATTACHED A NEW EGIA60AMT. AGAIN THE DEVICE ARTICULATED TOWARDS LEFT WITHOUT CONTROL. AT THE END THE SURGEON DECIDED TO REPLACE THE WHOLE IDRIVE SYSTEM AND EVERYTHING WORKED CORRECTLY. LESS THAN 30 MIN. DELAY, NO TISSUE LOSS OR DAMAGED, NO BLEEDING. NO REINFORCEMENT MATERIAL USED. PATIENT STATUS IS CORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149330 | IDRIVE ULTRA POWERED HANDLE 1 | REUSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3J0442UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | K121510| K102325| EGIA60AMT: EGIA 60 ARTICULATING MED/THICK SULU,| LOT #N3J1168UX, SN# (B)(4), MFG DATE: 09/2013,| INTB100: IDRIVE BATTERY PACK, LOT#C2L7201UX,| K083519| EGIAADAPT: ENDO GIA ADAPTER STANDARD, |