FDA Adverse Event
Malfunction
Summary report: N
CLASSIC SERIES¿ REUSABLE ACTIVE CORD FOR BOVIE¿/VALLEYLAB CONNECTION
MDR report key: 6984999
·
Received October 27, 2017
Report
- Report Number
- 6984999
- Event Type
- Malfunction
- Date Received
- October 27, 2017
- Date of Event
- August 17, 2017
- Report Date
- October 4, 2017
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- NLW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BUGBEE CORD AND BOVIE 10138 DUE TO BUGBEE CORD CATCHING FIRE WHILE IN SURGEON'S HAND; EXTINGUISHED WITH STERILE WATER AND BOVIE UNPLUGGED; SURGEON'S GOWN WITH VISIBLE HOLE NOTED; CHARGE NURSE AND ENGINEERING NOTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764362 | CLASSIC SERIES¿ REUSABLE ACTIVE CORD FOR BOVIE¿/VALLEYLAB CONNECTION | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL | NLW | GYRUS ACMI, INC. | C650-129A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |