MAUDE Adverse Event Report: MEDERI RF LLC MEDERI MDRF1 GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION

Model Number	177-5150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During stretta treatment, the generator turned itself off and it smelled like it was overheating.Fda safety report id# (b)(4).

• Brand Name: MEDERI MDRF1 GENERATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION
• Manufacturer (Section D): MEDERI RF LLC
• MDR Report Key: 9805292
• Report Number: MW5093616
• Device Sequence Number: 11545802
• Product Code: GEI
• UDI-Device Identifier: 00856219002102
• UDI-Public: 00856219002102
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 177-5150
• Device Catalogue Number: 177-5150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 75