FDA Adverse Event
Malfunction
Summary report: N
IDRIVE ULTRA POWERED HANDLE 1
MDR report key: 3988253
·
Received April 25, 2014
Report
- Report Number
- 1219930-2014-00334
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 27, 2014
- Report Date
- April 30, 2014
- Manufacturer
- COVIDIEN, FORMERLY US
- Product Code
- GDW
- PMA / PMN Number
- K121510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORT SENT TO FDA ON 04/25/2014.
Description of Event or Problem · 1
PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: CUSTOMER REPORTS: THE DEVICE WAS PROPERLY LOADED WITH TRISTAPLE RELOAD. THE DEVICE JAMMED PRIOR TO CUT AND SUTURE THE MAIN BRONCHUS. THE DEVICE PARTIALLY FIRED. THE SURGEON USED A NEW DEVICE (ECHELON POWER) OF THE COMPETITOR J+J. NO PT HARM. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252159 | IDRIVE ULTRA POWERED HANDLE 1 | REUSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US | N3G0047UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |