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

Model Number DACUK-NT

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Device return was requested however the adaptor cable was retained by the customer.The device history record was not reviewed as the batch number was not available.Based on the information received, the cause of the reported communication issue and subsequent cancelled procedure could not be determined.

Event Description

During a radiofrequency (rf) ablation procedure a cancellation occurred due to a communication issue.Following patient prep, when rf probes were connected to the generator the indicator light remained red.Different probes and adaptors were utilized and the generator was restarted but the issue was not resolved.The procedure was cancelled.There were no adverse patient consequences.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9880048
• MDR Text Key: 187167797
• Report Number: 3002953813-2020-00013
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/11/2020
• 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
• Patient Outcome(s): Other