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

Model Number VM46-9151

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

Liver tissue was getting burned from the insulation.

• Brand Name: AVALIGN
• Type of Device: 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
• MDR Text Key: 332489175
• Report Number: 1421101-2024-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00190776005627
• UDI-Public: 00190776005627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Date Device Manufactured: 02/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1