FDA Adverse Event
Malfunction
Summary report: N
XPS® HANDPIECE - VISAO®
MDR report key: 5276759
·
Received December 9, 2015
Report
- Report Number
- 1045254-2015-00420
- Event Type
- Malfunction
- Date Received
- December 9, 2015
- Report Date
- November 19, 2015
- Manufacturer
- MEDTRONIC XOMED INC.
- Product Code
- ERL
- PMA / PMN Number
- K011321
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: THE 3334610: SLEEVE 3334610, VISAO IRRIGATION, LOT 0205705402, MANUFACTURED 02/07/2012, 510K: K983224, ERL -- 3334625: GUARD 3334625, VISAO BUR W/O IRRIGATION, LOT 0205479507, MANUFACTURED 10/17/2011, 510K: K983224, ERL. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE PRODUCT IN QUESTION OVERHEATED DURING SURGERY. IT WAS UNCLEAR THAT HOW LONG THE PRODUCT WAS OVERHEATING. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO PATIENT IMPACT HAS BEEN REPORTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813244 | XPS® HANDPIECE - VISAO® | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | MEDTRONIC XOMED INC. | 3334800 | 65962300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |