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

Model Number	36717
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled post sedation.A rf3000 radiofrequency generator and a leveen electrode needle were selected for use in a liver tumor ablation procedure.The needle was inserted into the patient and reached the site for ablation when the physician requested to turn on the generator to start ablation.The generator was switched on, but power could not be increased.The active indication blue light did not turn on.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the procedure was cancelled post sedation.A rf3000 radiofrequency generator and a leveen electrode needle were selected for use in a liver tumor ablation procedure.The needle was inserted into the patient and reached the site for ablation when the physician requested to turn on the generator to start ablation.The generator was switched on, but power could not be increased.The active indication blue light did not turn on.The procedure was cancelled.No patient complications were reported.It was further reported that the patient was under general anesthesia when the procedure was cancelled and was referred for surgery since they were unable to be treated with radiofrequency ablation.The radiofrequency generator was used after this event successfully.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13446821
• Report Number: 2134265-2022-01078
• Device Sequence Number: 4321753
• Product Code: GEI
• UDI-Device Identifier: 08714729300632
• UDI-Public: 08714729300632
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K140498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 11/20/2023
• Device Model Number: 36717
• Device Catalogue Number: 36717
• Device Lot Number: 0026397612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/06/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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 Sex: Female