FDA Adverse Event
Malfunction
Summary report: N
NITINOL TC ELECTRODE
MDR report key: 6845620
·
Received September 6, 2017
Report
- Report Number
- 3006630150-2017-03272
- Event Type
- Malfunction
- Date Received
- September 6, 2017
- Date of Event
- August 21, 2017
- Report Date
- August 21, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 00813250013054
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT #: 050914, 100214, 020916, AND 021816 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM; MODEL #: TCN-15 LOT #: 062414 AND 122815 DESCRIPTION: NITINOL TC ELECTRODE, 150 MM.
Description of Event or Problem · 1
DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES SHOWED THAT ELECTRODE LOT # 050914 HAD DISCOLORED EPOXY WITH A CHIP OUT. ELECTRODE WITH LOT #100214 HAD DISCOLORED EPOXY AND WAS CRACKED. ELECTRODES WITH LOT # 123115, 021816, 062414, 020916, AND 122815 ARE DISCOLORED AND HAVE A CHIP OUT. 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 |
|---|---|---|---|---|---|---|---|
| 625467 | NITINOL TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | TCN-10 | 123115 | 00813250013054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |