FDA Adverse Event
Malfunction
Summary report: N
RF MULTIGEN
MDR report key: 2000566
·
Received February 1, 2011
Report
- Report Number
- 1811755-2011-00284
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 18, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K032601
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN 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 DID NOT WORK CORRECTLY. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND BACK UP EQUIPMENT WAS NOT AVAILABLE. THE PATIENT HAD ALREADY BEEN GIVEN LOCAL ANESTHETIC WHEN IT WAS DECIDED TO CANCEL THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF MULTIGEN | GENERATOR, LESION, RADIOFREQUENCY | GXD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |