FDA Adverse Event
Malfunction
Summary report: N
IDRIVE ULTRA POWERED HANDLE 1
MDR report key: 3974966
·
Received June 12, 2014
Report
- Report Number
- 1219930-2014-00441
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 23, 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
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: VATS. ACCORDING TO THE REPORTER: THE IDRIVE ARTICULATED ITSELF WITHOUT PRESSING THE BUTTON. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NOTHING FELL INTO THE PATIENT CAVITY. NO REINFORCEMENT MATERIAL WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346594 | IDRIVE ULTRA POWERED HANDLE 1 | REUSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3H1181UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ENDO GIA ADAPTER STANDARD: SN (B)(4),| EGIA 30 ARTICULATING VAS/MED SULU: LOT #N3M0567GX,| LOT #N3J0221UX, K121510, MFG DATE: 09/2013| K083519, MFG DATE: 12/2013, EXP DATE: 12/31/2018 |