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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: this date is unknown and was therefore estimated.
Event or Problem Description
It was reported insufficient roll off occurred.The patient underwent a radiofrequency ablation procedure on their kidney.An rf generator 3000 and an rf probe were used.Computed tomography (ct) imaging at this time showed everything appeared normal.At the 3 month follow up appointment it was observed that the tumor was not ablated.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: this date is unknown and was therefore estimated.Describe event or problem & e1 initial reporter title, initial reporter first name & initial reporter last name: updated.
Event or Problem Description
It was reported insufficient roll off occurred.The patient underwent a radiofrequency ablation procedure on their kidney.An rf generator 3000 and an rf probe were used.Computed tomography (ct) imaging at this time showed everything appeared normal.At the 3 month follow up appointment it was observed that the tumor was not ablated.No patient complications were reported.It was further reported that roll-off, which indicates the clinical endpoint, was achieved at the time of the index procedure.During the index procedure, a ct scan is used for placement of the probe only, they do not perform a ct with contrast to confirm ablation.The ablation is confirmed at the 3 month follow up using a ct scan with contrast, which in this case revealed the tumor was not ablated.

• 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
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13075351
• Report Number: 2134265-2021-16158
• Device Sequence Number: 4278844
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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 Model Number: 36725
• Device Catalogue Number: 36725
• Device Lot Number: 0121814006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown