FDA Adverse Event
Malfunction
Summary report: N
RF MULTIGEN
MDR report key: 2223256
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-03001
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 20, 2011
- Report Date
- July 20, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K032406
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
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 AN ERROR MESSAGE, INCLUDING THAT THE CABLE WAS NOT CONNECTED. TROUBLE SHOOTING WAS PERFORMED, BUT EXTENDED THE PROCEDURE TIME BY AN ADDITIONAL 30 MINUTES. THE CASE WAS COMPLETED USING THE SAME EQUIPMENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED OR ADVERSE CONSEQUENCE REPORTED.
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 |