MAUDE Adverse Event Report: MINTA MEDICAL LIMITED REUSABLE ELECTRODE, 10CM, SST; GENERATOR, LESION, RADIOFREQUENCY

Model Number	RF-SE-10
Medical Device Problem Codes	Thermal Decomposition of Device (1071); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 3005334138-2023-00457.It was reported that during an ablation procedure the patient experienced a secondary burn at the site of probe insertion.Reportedly, the burn was diagnosed months later and the would is being treated with epson salt compresses and medical honey.
Additional Manufacturer Narrative
Per the additional information received, this device is no longer reportable.
Event or Problem Description
Additional information received indicates that the burn was only at one site of insertion.Investigation was unable to determine which of the probe attributed to the issue.

• Brand Name: REUSABLE ELECTRODE, 10CM, SST
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• Manufacturer (Section G): MINTA MEDICAL LIMITED; caddick road; merseyside knowsley L34 9 HP; UK L34 9HP
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17925015
• Report Number: 3004617090-2023-00007
• Device Sequence Number: 17838309
• Product Code: GXD
• UDI-Device Identifier: 05415067025227
• UDI-Public: 05415067025227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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 Model Number: RF-SE-10
• Device Lot Number: M18993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 50 KG