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

Model Number	M001262500
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A soloist? needle was selected for use to treat an osteoid osteoma.The patient was sedated using general anesthesia.At the start of the procedure, while connecting the electrode, there was a high impedance error.Despite troubleshooting the error for between 2-3 hours, the error was unable to be resolved.There was no replacement device available, so the procedure was cancelled.There were no patient complications as a result of this event, and the patient was expected to fully recover.

• 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: 25128471
• Report Number: 2124215-2026-25115
• Device Sequence Number: 15612066
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: (01)08714729122487(17)280818(10)37575439
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: 0037575439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 38 KG