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

Model Number SYNERGYRF¿ CONSOLE

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2021

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 rf console, displayed a power surge message and charred the tip of the apollo wand that was being used. this was discovered during use in a procedure on (b)(6) 2021.

Manufacturer Narrative

Complaint confirmed visual evaluation did not show any external damaged.A burning smell was identified.During device functioning, the unit was power on and showed an rf output failure "error code 36".Error code refers to failure on the power supply (board damaged).The cause of this event is undetermined; however most likely cause for this event is excess of power supply to the device.

• 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: 12697301
• MDR Text Key: 283954953
• Report Number: 1220246-2021-03848
• 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

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYNERGYRF¿ CONSOLE
• Device Catalogue Number: AR-9800
• Device Lot Number: 11101347
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1