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

Model Number	AC0017
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was in for facet neurolysis.Two cannulas placed in patient neck, probes inserted into cannula.When placing probe into hub which is hooked to radio frequency machine patient started complaining of muscle spasms.Muscle contractions visualized by team in room.Unplugged probe from hub, contractions stopped.Tried replacing probe, patient experiencing contractions again.Placed cannula in different ports with patient continuing to experience contractions.Restarted machine with same result.Tried different machine with patient continued to experience contractions.Changed grounding pad out with no change.Then replaced cannula in neck.Probe placed in new cannula with machine working, were able to finish procedure with out problem.

• 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: 17744039
• Report Number: 17744039
• Device Sequence Number: 5281787
• Product Code: GEI
• UDI-Device Identifier: 20763000153650
• UDI-Public: (01)20763000153650(17)260901(10)BY22K004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2023
• Report Date (Section F): 08/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: AC0017
• Device Catalogue Number: AC0017
• Device Lot Number: BY22K004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/22/2023