MAUDE Adverse Event Report: ARTHREX, INC. SYNERGYRF¿ CONSOLE; ELECTROSURG CUT/COAG DEVICE

Model Number SYNERGYRF¿ CONSOLE

Device Problem Overheating of Device (1437)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

On 7/29/2022, it was reported by a sales representative via email that an ar-8330h shaver handpiece caught on fire when it was plugged in and laying on the mayo stand.Shortly after, the room experienced a power outage.An ar-6480 dualwave arthroscopy fluid management system, an ar-8305 synergy resection shaver console, and an ar-9800 synergy rf console were all connected and running during this incident.This was discovered during a procedure.Additional information 10/5/2022: per the sales representative: the hospital¿s biomedical engineer team did their own internal investigation and found that the shaver disposable was bent during the procedure which caused the inner and outer sleeves to create friction and heat and catch fire.On 02/17/2023, the complaint reporter provided additional information confirming that the event occurred after the device had been used in the procedure.In addition, it was informed that the disposable was on the mayo stand when someone accidentally stepped on the footswitch and activated the shaver.This information confirmed arthrex's hypothesis that the device had been activated without irrigation, causing the excessive heating of the disposable.On the same day, arthrex assessed the effects of activating disposable attachments without irrigation, affirming that irrigation is essential in maintaining the device at appropriate temperatures during operation.The labeling for disposable attachments, dfu-0215-7, includes two precautions related to running the device without irrigation flow, indicating that doing so will result in irreversible damage, excessive heating, and may cause thermal burns.

Manufacturer Narrative

See attached for supplier evaluation.

• Brand Name: SYNERGYRF¿ CONSOLE
• Type of Device: ELECTROSURG CUT/COAG DEVICE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18230946
• MDR Text Key: 329279482
• Report Number: 1220246-2023-09000
• 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
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11039495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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