FDA Adverse Event
Malfunction
Summary report: N
RF MULTIGEN
MDR report key: 2223257
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-03002
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 21, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K032406
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE MADE IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
DURING AN RF PROCEDURE, THE DEVICE DISPLAYED A GROUND PAD ERROR MESSAGE. THE PROCEDURE WAS DELAYED 45 MINUTES WHILE BACK UP EQUIPMENT WAS OBTAINED. THE SURGERY WAS COMPLETED AS PLANNED.
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 |