FDA Adverse Event Malfunction Summary report: N

NITINOL TC ELECTRODE

MDR report key: 6462728 · Received April 5, 2017

Report

Report Number: 3006630150-2017-01327
Event Type: Malfunction
Date Received: April 5, 2017
Date of Event: March 6, 2017
Report Date: March 6, 2017
Manufacturer: COSMAN MEDICAL
Product Code: GXI
PMA / PMN Number: K050084
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DEVICE ANALYSIS INDICATED THAT ALL ELECTRODES FAILED VISUAL INSPECTION. ALL ELECTRODES HAD CHIPS OUT OF THE EPOXY AND DISCOLORATION IN THE EPOXY. ALL ELECTRODES PASSED THE TEMPERATURE TEST. 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.

Additional Manufacturer Narrative · 1

EXPIRATION DATE: NA, MODEL #: TCN-10, LOT#: 121716, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 1. MODEL #: TCN-10, LOT#: 020916, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 2. MODEL #: TCN-10, LOT#: 111516, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 1. MODEL #: TCN-5, LOT#: 122316, DESCRIPTION: NITINOL TC ELECTRODE, 50 MM, QUANTITY: 1.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODES HAD ERODED CAUSING BLOOD AND FLUIDS TO SEEP INSIDE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODES HAD ERODED CAUSING BLOOD AND FLUIDS TO SEEP INSIDE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE GLUE INSIDE THE HUB OF THE ELECTRODES HAD ERODED CAUSING BLOOD AND FLUIDS TO SEEP INSIDE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
242148	NITINOL TC ELECTRODE	ELECTRODE	GXI	COSMAN MEDICAL	TCN-5	022616

Patients

Seq	Age	Sex	Outcome	Treatment
1