MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLOIST?; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	M001262500
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled post sedation.A soloist? single needle electrode was selected for use in a radio frequency ablation procedure in an osteoid osteoma with benign tumor.The patient was under general anesthesia.After obtaining access and deploying the device, an attempt was made to start ablation, but the generator showed an error 2.Troubleshooting was attempted, but the error 2 displayed continuously, so the procedure was cancelled.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the lot # is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the procedure was cancelled post sedation.A soloist? single needle electrode was selected for use in a radio frequency ablation procedure in an osteoid osteoma with benign tumor.The patient was under general anesthesia.After obtaining access and deploying the device, an attempt was made to start ablation, but the generator showed an error 2.Troubleshooting was attempted, but the error 2 displayed continuously, so the procedure was cancelled.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the procedure was cancelled post sedation.A soloist? single needle electrode was selected for use in a radio frequency ablation procedure in an osteoid osteoma with benign tumor.The patient was under general anesthesia.After obtaining access and deploying the device, an attempt was made to start ablation, but the generator showed an error 2.Troubleshooting was attempted, but the error 2 displayed continuously, so the procedure was cancelled.There were no patient complications as a result of this event.Additional information reported that the needle electrode was able to be placed at the desired location and all protocols were followed, but it was unable to reach the maximum impedance.The impedance calculator was floating around 35-45 during all three placements of 15 minutes.

• Brand Name: SOLOIST?
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 23266147
• Report Number: 2124215-2025-71394
• Device Sequence Number: 13298498
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: (01)08714729122487(17)271011(10)35072109
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K053128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2026

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: M001262500
• Device Catalogue Number: M001262500
• Device Lot Number: 0035072109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 01/22/2026; 06/04/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/23/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Male