FDA Adverse Event
Malfunction
Summary report: N
NITINOL TC ELECTRODE
MDR report key: 6820193
·
Received August 25, 2017
Report
- Report Number
- 3006630150-2017-03211
- Event Type
- Malfunction
- Date Received
- August 25, 2017
- Date of Event
- August 15, 2017
- Report Date
- August 15, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 00813250013054
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: CSK-TC10 LOT: 052516 MODEL DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: ONE.
Description of Event or Problem · 1
DEVICE ANALYSIS PERFORMED ON THE RETURNED TCN-10 ELECTRODE SHOWED THAT THE EPOXY WAS CHIPPED OUT AND DISCOLORED. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED. IN ADDITION THE DEVICE ANALYSIS ON THE CSK-TC10 ELECTRODE CONFIRMED THAT THE SHAFT WAS BROKEN OFF AT THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602203 | NITINOL TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | TCN-10 | 120715 | 00813250013054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |