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

Model Number	36703
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled post-sedation.A rf3000 radiofrequency generator and two soloist single needle electrodes were selected for use in radiofrequency treatment of an osteoid osteoma, a benign bone tumor that causes pain.The patient was sedated.Everything went well according to the protocol until the start of ablation.The device gave an e02 error message when the start button was pushed, and impedance ranged from 400 to 500 ohms.Attempts were made to start and stop the device, flush saline into the bone canal and ablation tip, dilate canal, change needle position and orientation, check placement of the earthing hoses, and replace new strands (e.G., needle); however, the device continued to give the e02 code and would not work.The patient could not be treated, and the procedure was cancelled.No patient complications were reported.

• Brand Name: SOLOIST
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12006033
• Report Number: 2134265-2021-07675
• Device Sequence Number: 3096578
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: 08714729122487
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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 Expiration Date: 03/02/2024
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0026913114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/15/2021
• Patient Sequence Number: 1