FDA Adverse Event
Malfunction
Summary report: N
NITINOL TC ELECTRODE
MDR report key: 6863597
·
Received September 13, 2017
Report
- Report Number
- 3006630150-2017-03584
- Event Type
- Malfunction
- Date Received
- September 13, 2017
- Date of Event
- September 5, 2017
- Report Date
- September 5, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 00813250013054
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION DATE: NA MODEL: TCN-10 LOT: 102716 ¿ QUANTITY ONE LOT: 102416 ¿ QUANTITY ONE LOT: 31517 ¿ QUANTITY TWO MODEL DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY OF ELECTRODES - FOUR.
Description of Event or Problem · 1
THE RETURNED ELECTRODES WERE ANALYZED AND VISUAL INSPECTION ON ALL FOUR ELECTRODES FOUND THAT THE EPOXY HAS 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 |
|---|---|---|---|---|---|---|---|
| 642464 | NITINOL TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | TCN-10 | 102716 | 00813250013054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |