MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RF 3000 RADIO FREQUENCY GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36739
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insufficient roll off.A radio frequency ablation procedure was being performed on a tumor for a patient.The leveen needle was being used for this procedure.When the needle was deployed after puncture, it was reported that it was unable to achieve sufficient roll off.There were no other complications that were reported.

• Brand Name: RF 3000 RADIO FREQUENCY GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9818084
• Report Number: 2134265-2020-02811
• Device Sequence Number: 16468757
• Product Code: GEI
• UDI-Device Identifier: 08714729404262
• UDI-Public: 08714729404262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 36739
• Device Catalogue Number: 36739
• Device Lot Number: 061705-008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1