FDA Adverse Event
Malfunction
Summary report: N
CSK-TC ELECTRODE
MDR report key: 6745790
·
Received July 26, 2017
Report
- Report Number
- 3006630150-2017-02656
- Event Type
- Malfunction
- Date Received
- July 26, 2017
- Date of Event
- June 28, 2017
- Report Date
- June 28, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 00813250011524
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: CSK-TC10-3M LOT #: 041617 DESCRIPTION: CSK 100 MM TC ELECTRODE WITH 3M CABLE.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION PERFORMED ON ELECTRODE LOT# 040612 SHOWED THAT THE ELECTRODE SHAFT WAS BROKEN OFF AT THE HUB. DEVICE EVALUATION PERFORMED ON ELECTRODE LOT# 041617 SHOWED THE THERMOCOUPLE HAS MIGRATED FROM TIP TO A DIFFERENT POSITION ON THE SHAFT. THE ELECTRODE SHAFT WAS BENT, DUE TO EXTERNAL MECHANICAL FORCE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A USED ELECTRODE WAS FOUND TO HAVE A RUSTY WIRE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A USED ELECTRODE WAS FOUND TO HAVE A RUSTY WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525077 | CSK-TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | CSK-TC10-3M | 040612 | 00813250011524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |