MAUDE Adverse Event Report: ARTHREX, INC. SYNERGYRF¿ CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number SYNERGYRF¿ CONSOLE

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2021, it was reported by a sales representative via sems that an ar-9800 synergyrf¿ console stopped working, swapped to test another wand and the error message "burn in required".This was discovered during use with no impact to the patient.Additional information on 12/02/21: the case was delayed by 20 minutes.The surgeon completed the case without using rf.The rep stated the patient is fine to date without injury per the surgeon.

Manufacturer Narrative

Complaint confirmed visual evaluation did not showed any external damaged.A burning smell was identified.During device functioning, the unit was power on and showed a "system burn in required" error.The cause of this event is undetermined; however most likely causes for this event are excess of power supply to the device, memory corrupted and if there is a power interruption of 30-90 seconds or longer.

• Brand Name: SYNERGYRF¿ CONSOLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13054507
• MDR Text Key: 283955495
• Report Number: 1220246-2021-04139
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: 00888867142473
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYNERGYRF¿ CONSOLE
• Device Catalogue Number: AR-9800
• Device Lot Number: 10113239
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other