FDA Adverse Event
Malfunction
Summary report: N
RF GEN OBSOLETE REPLACED BY 0406900000
MDR report key: 2223259
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-03003
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 22, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K063489
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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
AT THE BEGINNING OF AN RF PROCEDURE, THE TOUCH SCREEN OF THE DEVICE MALFUNCTIONED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF GEN OBSOLETE REPLACED BY 0406900000 | GXD | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |