FDA Adverse Event
Malfunction
Summary report: N
NITINOL TC ELECTRODE
MDR report key: 6843743
·
Received September 5, 2017
Report
- Report Number
- 3006630150-2017-03150
- Event Type
- Malfunction
- Date Received
- September 5, 2017
- Date of Event
- August 16, 2017
- Report Date
- August 16, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 00813250013054
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION DATE: NA ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT#: 052516 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 3 MODEL #: TCN-15 LOT#: 051016 DESCRIPTION: NITINOL TC ELECTRODE, 150 MM TOTAL QUANTITY: 1
Description of Event or Problem · 1
DEVICE EVALUATION WAS PERFORMED ON MULTIPLE ELECTRODES AND SHOWED THAT THE EPOXY HAS A CHIP OUT AND DISCOLORATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623546 | NITINOL TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | TCN-10 | 052016 | 00813250013054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |