FDA Adverse Event
Malfunction
Summary report: N
IDRIVE ULTRA POWERED HANDLE 1
MDR report key: 3850798
·
Received March 21, 2014
Report
- Report Number
- 1219930-2014-00224
- Event Type
- Malfunction
- Date Received
- March 21, 2014
- Date of Event
- February 26, 2014
- Report Date
- February 27, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY US SUR
- Product Code
- GDW
- PMA / PMN Number
- K121510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: STAPLER MOVED BY ITSELF ROTATION WISE. ONE TOUCH AND IT GOES 180 DEGREES. SOMETIMES DIDN'T TOUCH AND IT MOVED ITSELF. THERE WAS NO UNANTICIPATED TISSUE LOSS. 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 |
|---|---|---|---|---|---|---|---|
| 170374 | IDRIVE ULTRA POWERED HANDLE 1 | REUSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN LP, FORMERLY US SUR | N3G0198UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MANUF. DATE: 06/2013, K121510| SERIAL #(B)(4), LOT #N3F0443UX,| ENDO GIA ADAPTER STANDARD, EGIAADAPT, |