FDA Adverse Event
Malfunction
Summary report: N
NITINOL TC ELECTRODE
MDR report key: 6828412
·
Received August 29, 2017
Report
- Report Number
- 3006630150-2017-03309
- Event Type
- Malfunction
- Date Received
- August 29, 2017
- Date of Event
- August 21, 2017
- Report Date
- August 21, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 00813250017502
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION DATE: NA. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # TCN-10-3M LOT # 070116 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM. A TOTAL OF TWO DEVICES WERE RETURNED AND ANALYZED
Description of Event or Problem · 1
DEVICE ANALYSIS PERFORMED SHOWED THAT BOTH ELECTRODES HAVE DISCOLORED AND CHIPPED OUT EPOXY. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES, THE EPOXY BECOMES BRITTLE AND DISCOLORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608419 | NITINOL TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | TCN-10-3M | 070116 | 00813250017502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |