MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. ACCURIAN; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	AC0010
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the physician this has been reported before.Unprompted pulsation (electrical current) from rfa machine to patient through needle cannulas.

• Brand Name: ACCURIAN
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 25650462
• Report Number: 25650462
• Device Sequence Number: 12228672
• Product Code: GEI
• UDI-Device Identifier: 20763000153582
• UDI-Public: (01)20763000153582(17)290528(10)BY25E027
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026
• Report Date (Section F): 06/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: AC0010
• Device Catalogue Number: AC0010
• Device Lot Number: BY25E027
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/23/2026