TRUSCULPT ID
Report
- Report Number
- 2954354-2022-00002
- Event Type
- Injury
- Date Received
- June 7, 2022
- Date of Event
- April 12, 2022
- Report Date
- June 3, 2022
- Manufacturer
- CUTERA, INC.
- Product Code
- PBX
- UDI-DI
- 00816722021427
- PMA / PMN Number
- K180709
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 501
Narratives
USER FACILITY REPORTED A SIGNIFICANT BURN (SMALL FULL-THICKNESS SURROUNDED BY A LARGER PARTIAL THICKNESS) ON THE LOWER EDGE OF THE BOVIE NEUTRAL ELECTRODE PAD TAB FOUND IMMEDIATELY AFTER AN RF TREATMENT FOR ABDOMINAL FAT REDUCTION. IMMEDIATELY POST-TREATMENT PHOTOS AND PHOTOS TAKEN AT FOLLOW-UP VISITS THROUGH 38 POST TREATMENT WERE PROVIDED. IT IS APPARENT FROM THE IMMEDIATE POST-TREATMENT PHOTO OF THE FULL-THICKNESS BURN (2.0 CM WIDTH X 0.4 CM LENGTH) AND SURROUNDING PARTIAL-THICKNESS BURN (~4 CM WIDTH X ~1 CM LENGTH) THAT, CONTRARY TO THE IFU, THE RETURN CABLE CLAMP WAS NOT FULLY COVERING THE EXPOSED BARE-METAL CONDUCTORS OF SPLIT-ELECTRODE BOVIE NEUTRAL ELECTRODE PAD TAB. THE FULL-THICKNESS BURN EXACTLY MATCHED IN LOCATION, WIDTH, AND LENGTH THE IMPRINT OF THE NEUTRAL ELECTRODE PADE AND TAB IN THE PATIENT'S SKIN, AND EXTENDED FROM THE HYDROGEL-COATED EDGE OF THE TAB CONDUCTORS TO THE POINT (4 MM BELOW) WHERE THE BARE-MENTAL CONDUCTORS WERE COVERED BY THE RETURN CABLE CLAMP.
FULL AND PARTIAL THICKNESS BURNS AT CONNECTION POINT BETWEEN THE RETURN CABLE AND BOVIE NEUTRAL ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2197433 | TRUSCULPT ID | ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES | PBX | CUTERA, INC. | TRUSCULPT ID | 00816722021427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Female | Other |