FDA Adverse Event
Malfunction
Summary report: N
CABLE, MONOPOLAR OPTIMA
MDR report key: 472316
·
Received July 1, 2003
Report
- Report Number
- 2124979-2003-00014
- Event Type
- Malfunction
- Date Received
- July 1, 2003
- Date of Event
- March 31, 2003
- Report Date
- June 30, 2003
- Manufacturer
- ACMI CORPORATION
- Product Code
- HFG
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
"MONOPOLAR CABLE FROM L-HOOK TO CAUTERY MACHINE BROKE NEAR THE OPERATING END. A VISIBLE FLASH/SPARK CAME FROM THE CORD AT THE BREAK NO BURNS WERE NOTED ON ANY AREA NEAR PT." NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CABLE, MONOPOLAR OPTIMA | * | HFG | ACMI CORPORATION | 006358-901 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |