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

Model Number RF-SE-10

Device Problems Thermal Decomposition of Device (1071); No Apparent Adverse Event (3189)

Patient Problems Partial thickness (Second Degree) Burn (2694); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

Per the additional information received, this device is no longer reportable.

Event 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
• Type of Device: 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
• MDR Text Key: 325534019
• Report Number: 3004617090-2023-00007
• Device Sequence Number: 1
• Product Code: GXD
• UDI-Device Identifier: 05415067025227
• UDI-Public: 05415067025227
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 50 KG