FDA Adverse Event
Malfunction
Summary report: N
RF MULTIGEN
MDR report key: 2230989
·
Received July 19, 2011
Report
- Report Number
- 1811755-2011-02598
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 28, 2011
- Report Date
- June 28, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K071482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
DURING AN RF PROCEDURE, THE DEVICE DISPLAYED A MISMATCH ERROR MESSAGE. THE CASE WAS DELAYED 30 MINS. BACK UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF MULTIGEN | GXD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |