FDA Adverse Event
Other
Summary report: N
SUPER MULTIVAC 50 WITH INTEGRATED CABLE
MDR report key: 1010127
·
Received March 12, 2008
Report
- Report Number
- 2951580-2008-00019
- Event Type
- Other
- Date Received
- March 12, 2008
- Date of Event
- January 29, 2008
- Report Date
- March 7, 2008
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- GEI
- PMA / PMN Number
- K070958
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DATE OF EVENT WAS NOT PROVIDED. AN APPROX DATE WAS PROVIDED FOR THIS REPORT. IT IS UNK IF THE DEVICE WAS REPROCESSED. AWAITING FURTHER INFO REGARDING THE AVAILABILITY OF THE DEVICE FOR INVESTIGATION.
Description of Event or Problem · 1
IN EARLY 2008, A CLINICAL INCIDENT INVOLVING A SUPER MULTIVAC 50 WITH INTEGRATED CABLE WAS REPORTED TO ARTHROCARE CORP. DURING A PROCEDURE INVOLVING THE RIGHT KNEE JOINT OF PT, IT WAS REPORTED THAT ELECTRODE HAD DETACHED FROM THE TIP OF THE WAND AND REMAINS IN THE PT'S RIGHT KNEE JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPER MULTIVAC 50 WITH INTEGRATED CABLE | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | GEI | ARTHROCARE CORP. | NA | E931870-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |