MAUDE Adverse Event Report: LEONHARD LANG GMBH MEGADYNE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RS271A30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On april 21st, 2026, we have been informed of an adverse event involving two dispersive electrodes.An unknown procedure was performed uw health in madison (usa).Megadyne dispersive electrode catalogue number: 0855c (our model: rs271a30) and an unknown generator had been used.The initial report was stating that: "it was reported by distributor per account that there are two patient injuries occurring on consecutive days.Pads are burning patients.Unintended thermal injury less than 2nd degree." it was also stated in the initial report that the involved "devices are available for return." no information about the generator model, the power settings, the patients, how the skin was prepared, how the injuries were treated afterwards and a filled in questionnaire have been disclosed to us so far.
Additional Manufacturer Narrative
Retained samples of the concerned lot number have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples of the concerned lot number.All tested samples were found to perform within limits.No faults were detected.We have requested further information, questionnaires to be completed and the concerned customer samples for testing.We will provide a follow up report once any further will become available.
Event or Problem Description
On april 21st, 2026 we have been informed of an adverse event involving two dispersive electrodes.An unknown procedure was performed (b)(6) (usa).Megadyne dispersive electrode catalogue number 0855c (our model rs271a30) and an unknown generator had been used.The initial report was stating that: "it was reported by distributor per account that there are two patient injuries occurring on consecutive days.Pads are burning patients.(.) unintended thermal injury less than 2nd degree." it was also stated in the initial report that the involved "devices are available for return." no information about the generator model, the power settings, the patients, how the skin was prepared, how the injuries were treated afterwards and a filled in questionnaire have been disclosed to us so far.
Additional Manufacturer Narrative
Retained samples of the concerned lot number have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples of the concerned lot number.All tested samples were found to perform within limits.No faults were detected.We have requested further information, questionnaires to be completed and the concerned customer samples for testing but none have been received despite repeated requests.As no further information or a filled in questionnaire or the concerned customer samples was available despite repeated requests it was not possible to determine if a user-error has contributed to or caused the claimed incident.We therefore consider the investigation and the report closed.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: thomas recheis ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 25212713
• Report Number: 8020045-2026-00015
• Device Sequence Number: 10473121
• Product Code: GEI
• UDI-Device Identifier: 19005531507774
• UDI-Public: (01)19005531507774
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: RS271A30
• Device Catalogue Number: 0855C
• Device Lot Number: 250924-2403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown