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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SYNERGYRF¿ CONSOLE; ELECTROSURG CUT/COAG DEVICE
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ARTHREX, INC. SYNERGYRF¿ CONSOLE; ELECTROSURG CUT/COAG DEVICE Back to Search Results
Device Problem Overheating of Device (1437)
Patient Problem Insufficient Information (4580)
Event Date 11/13/2023
Event Type  malfunction  
Event Description
On (b)(6) 2023, it was reported by a sales representative via sems-06399752 that an ar-9800 synergy rf console was heating up the wand.This occurred during a case where the wand heated while in use.There was no case involvement.
 
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.
 
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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 Key18288778
MDR Text Key330017355
Report Number1220246-2023-09290
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/13/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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