FDA Adverse Event
Malfunction
Summary report: N
IDRIVE ULTRA POWERED HANDLE 1
MDR report key: 3883164
·
Received February 19, 2014
Report
- Report Number
- 1219930-2014-00118
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- January 27, 2014
- Report Date
- January 27, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K121510
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: RIGHT UPPER LOBECTOMY. ACCORDING TO THE REPORTER: UPON LOADING 6TH SULU (60, PURPLE), IT ROTATED TO THE MAXIMUM BY ITSELF AND THEN RETURNED OT THE ORIGINAL POSITION. DOCTOR CONTINUED USING THE DEVICE WAS FIRED UNSUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. NO PT HARM. NOTHING FELL INTO THE PT CAVITY. NO DELAY. NO BLEEDING. NO REINFORCEMENT MATERIAL WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105945 | IDRIVE ULTRA POWERED HANDLE 1 | REUSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL | N3A0717UX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SERIAL#: (B)(4), LOT#: N2L0013UX,| ENDO GIA ADAPTER STANDARD, EGIAADAPT,| MFG. DATE: 11/2012, K121510. |