FDA Adverse Event
Malfunction
Summary report: N
MULTIGEN RADIOFREQUENCY GENERATOR
MDR report key: 2465433
·
Received February 16, 2012
Report
- Report Number
- 1811755-2012-00517
- Event Type
- Malfunction
- Date Received
- February 16, 2012
- Date of Event
- January 17, 2012
- Report Date
- January 17, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GXD
- PMA / PMN Number
- K071482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DID NOT FUNCTION AND WAS READING AN ERROR MESSAGE DURING THE COURSE OF A PROCEDURE. IT IS UNKNOWN AT THIS TIME WHAT TYPE OF ANESTHESIA WAS USED. THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIGEN RADIOFREQUENCY GENERATOR | GXD | STRYKER INSTRUMENTS KALAMAZOO | LES6201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |