MAUDE Adverse Event Report: NEUROTHERM, INC NEUROTHERM¿ ADAPTOR CABLE NT GENERATOR TO DISPOSABLE; MEDICAL DEVICE ELECTRICAL CABLE, REUSABLE

Model Number DACUK-NT

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: (b)(4).During a procedure port 1 on the generator displayed an unsafe probe error message when going into lesion mode.The procedure was cancelled and there were no adverse consequences to the patient.Further troubleshooting determined the issue was due to two generator adapter cables.

• Brand Name: NEUROTHERM¿ ADAPTOR CABLE NT GENERATOR TO DISPOSABLE
• Type of Device: MEDICAL DEVICE ELECTRICAL CABLE, REUSABLE
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer (Section G): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7604827
• MDR Text Key: 111151506
• Report Number: 3002953813-2018-00036
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 05415067021335
• UDI-Public: 5415067021335
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DACUK-NT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NEUROTHERM¿ ADAPTOR CABLE