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

Model Number	36703
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that an e02 error occurred.A soloist single needle electrode was selected for use during a osteoid osteoma radiofrequency ablation procedure.Patient was sedated and ready with the pads connected to the radiofrequency generator, and when the electrode was connected it repeatedly gave an e02 error.The procedure was eventually aborted.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device returned and evaluated by manufacturer.One electrode needle and cable were returned for analysis.No visual damages defects were observed on the electrode needle and cable.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.Device inspected according to procedures.Resistance testing was performed on the needle and cable and both were within specification.
Event or Problem Description
It was reported that an e02 error occurred.A soloist single needle electrode was selected for use during a osteoid osteoma radiofrequency ablation procedure.Patient was sedated and ready with the pads connected to the radiofrequency generator, and when the electrode was connected it repeatedly gave an e02 error.The procedure was eventually aborted.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: 12271961
• Report Number: 2134265-2021-09926
• Device Sequence Number: 14335744
• Product Code: GEI
• UDI-Device Identifier: 08714729122487
• UDI-Public: 08714729122487
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 02/01/2024
• Device Model Number: 36703
• Device Catalogue Number: 36703
• Device Lot Number: 0026737081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1