MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES AVALIGN; RIGHT ANGLE ELECTRODE

Model Number	VM46-9151
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Serious Injury
Event or Problem Description
Liver tissue was getting burned from the insulation.

• Brand Name: AVALIGN
• Common Device Name: RIGHT ANGLE ELECTRODE
• Manufacturer (Section D): AVALIGN TECHNOLOGIES; 626 cooper ct; schaumburg IL 60173
• Manufacturer Contact: jennifer staunton ; 626 cooper ct; schaumburg, IL 60173
• MDR Report Key: 18479677
• Report Number: 1421101-2024-00001
• Device Sequence Number: 17838859
• Product Code: GEI
• UDI-Device Identifier: 00190776005627
• UDI-Public: 00190776005627
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Model Number: VM46-9151
• Device Lot Number: 154887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown