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

Model Number	36725
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported insufficient roll-off occurred.A radiofrequency ablation procedure of the liver was being performed.A 5cm leveen standard electrode was used with an rf3000 generator to ablate the tissue.After about 2 hours, roll-off was unable to be achieved.Therefore, they finished the procedure without the desired result.Another probe was not attempted.No patient complications 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: 9810974
• Report Number: 2134265-2020-02833
• Device Sequence Number: 3002853
• Product Code: GEI
• UDI-Device Identifier: 08714729375463
• UDI-Public: 08714729375463
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/10/2020

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 Expiration Date: 10/15/2013
• Device Model Number: 36725
• Device Catalogue Number: 36725
• Device Lot Number: 091603-025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1