FDA Adverse Event
Injury
Summary report: N
QUANTUM 2 SYSTEM
MDR report key: 3060309
·
Received April 11, 2013
Report
- Report Number
- 3006524618-2013-00146
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 11, 2013
- Manufacturer
- ARTHROCARE CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K071709
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A DIAGNOSTIC SHOULDER ARTHROSCOPY PROCEDURE USING THE QUANTUM 2 SYSTEM ALONG WITH A SUPER TURBOVAC 90 IFS, THE PATIENT SUSTAINED BURNS IN THE AXILLA REGION. THE SURGEON ALLEGED THAT THE BURN POSSIBLY RESULTED FROM CABLING ON THE QUANTUM 2 UNIT. THE BURN AREA WAS IMMEDIATELY TREATED WITH SILVADENE CREAM. NO FURTHER INFORMATION WAS PROVIDED AS TO THE SEVERITY OF THE BURN, ADDITIONAL POST OPERATIVE TREATMENT RECEIVED, OR ANY ADDITIONAL DETAILS REGARDING THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155291 | QUANTUM 2 SYSTEM | OPERATOR CONSOLE, DIATHERMY UNIT | GEI | ARTHROCARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other | EXPIRATION DATE:| ASH4250-01 SUPER TURBOVAC 90 IFS: LOT #1031258 |