FDA Adverse Event
Malfunction
Summary report: N
RFB VULCAN GENERATOR CE MARK
MDR report key: 6768489
·
Received August 4, 2017
Report
- Report Number
- 1643264-2017-00458
- Event Type
- Malfunction
- Date Received
- August 4, 2017
- Date of Event
- July 7, 2017
- Report Date
- August 4, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GEI
- PMA / PMN Number
- K991140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ONE REFURBISHED VULCAN RF GENERATOR WAS RECEIVED. COMPLAINT OF GROUND PAD ERRORS WERE CONFIRMED. PRODUCT FAILED FUNCTIONAL TESTING WITH NEM CIRCUIT ERROR. NEM CIRCUIT TP3 ON RF PCB PN: 1180215 IS OUT OF SPEC WITH 9.64 VOLT READING CAUSING ERROR ALARM. SPEC IS 9.8 TO 10.2 VOLTS. THE RF BOARD WAS RECALIBRATED INCLUDING THE NEM CIRCUIT AND UNIT PASSED FUNCTIONAL TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VULCAN GENERATOR DISPLAYED AN ERROR MESSAGE. NO INJURIES OR COMPLICATIONS WERE REPORTED AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549509 | RFB VULCAN GENERATOR CE MARK | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |