FDA Adverse Event
Malfunction
Summary report: N
MULTIGEN RADIOFREQUENCY GENERATOR
MDR report key: 3192828
·
Received June 27, 2013
Report
- Report Number
- 0001811755-2013-01483
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 6, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- GXD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT COULD NOT BE CONFIRMED. HOWEVER, BASED ON CONSULTATION WITH A SUBJECT MATTER EXPERT, AND BASED ON THE FACT THAT NO FAILURES OR MALFUNCTIONS WERE OBSERVED DURING PRODUCT EVALUATION, A ROOT CAUSE FOR THE ALLEGED EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNINTENDED STIMULATION WHEN THE SCREEN OF THE DEVICE WAS TOUCHED. THERE WERE NO ADVERSE CONSEQUENCES, NO DELAY AND NO MEDICAL INTERVENTION REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNINTENDED STIMULATION WHEN THE SCREEN OF THE DEVICE WAS TOUCHED. THERE WERE NO ADVERSE CONSEQUENCES, NO DELAY AND NO MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291973 | MULTIGEN RADIOFREQUENCY GENERATOR | GENERATOR, LESION, RADIOFREQUENCY | GXD | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |