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

Model Number	36725
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported pad burns occurred.The patient was undergoing radiofrequency ablation (rfa) of a fibrotic liver tumor.A leveen standard was used with a rf3000 radio frequency generator.Four non bsc grounding pads were positioned on the patients thighs per the dfu.The ablation was performed for 90 minutes in the first tumor and 60 minutes in the second tumor.The highest power was 200 watts.Roll off was achieved.At the end of the procedure, while removing the pads, burns were observed on both legs under all four pads.The burns were second and third degree and ranged from 4x4cm to 5x5cm.There were no issues with pad contact and the contact and skin conditions were reported to be monitored during the procedure.The patient was treated with topical cream and antibiotics.There were no further complications reported and the patient condition was stable.

• 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: 9195102
• Report Number: 2134265-2019-12540
• Device Sequence Number: 2550936
• Product Code: GEI
• UDI-Device Identifier: 08714729375463
• UDI-Public: 08714729375463
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 36725
• Device Catalogue Number: 36725
• Device Lot Number: 041807-010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 77