FDA Adverse Event
Malfunction
Summary report: N
NITINOL TC ELECTRODE
MDR report key: 6505592
·
Received April 19, 2017
Report
- Report Number
- 3006630150-2017-01413
- Event Type
- Malfunction
- Date Received
- April 19, 2017
- Date of Event
- March 23, 2017
- Report Date
- March 23, 2017
- Manufacturer
- COSMAN MEDICAL
- Product Code
- GXI
- UDI-DI
- 0813250013054
- PMA / PMN Number
- K050084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION DATE: NA. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10, LOT #: 021916, 111516, AND 121716, DESCRIPTION: NITINOL TC ELECTRODE, 150 MM. MODEL #: TCN-5, LOT #: 022616, DESCRIPTION: NITINOL TC ELECTRODE, 50 MM.
Additional Manufacturer Narrative · 1
DEVICE ANALYSIS SHOWED THAT ELECTRODES #(B)(4) HAVE BROKEN THERMOCOUPLES. DEVICE ANALYSIS OF ALL OTHER ELECTRODES FOUND NOTHING WRONG.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODES HAD ERODED.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODES HAD ERODED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286523 | NITINOL TC ELECTRODE | ELECTRODES | GXI | COSMAN MEDICAL | TCN-10 | 020916 | 0813250013054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |