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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Retained samples of the concerned lot number have been inspected visually and tested electrically.Also an adhesion test was performed.All tested electrodes were within limits, no failure could be detected.The involved device has not been made available to us.No further details have been disclosed so far.We will provide a follow up report once any further information is available.
Event or Problem Description
On november 04th, 2025, we have been informed of a product problem involving a dispersive electrode.An unknown procedure was performed at (b)(6) hospital in (b)(6).A megadyne dispersive electrode catalog number: 0855c (our model: rs271a30) and an unknown generator had been used.The initial report was stating that: "it was reported by healthcare professional that the megadyne neutral electrodes allow for the cautery generator to show "ready" when the electrodes are not attached to the patient.This can allow the pad to not be attached to the patient fully and therefore not grounding the patient during a procedure and could cause harm.There is no patient injury reported.Device is available for return." further on we have been informed that "no patient consequence, no signs, symptoms or patient involvement." no further information was provided on the generator model, the generator settings and other further details that may have an influence on the investigation.
Event or Problem Description
On (b)(6) 2025 we have been informed of a product problem involving a dispersive electrode.An unknown procedure was performed (b)(6).A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator had been used.The initial report was stating that: "it was reported by healthcare professional that the megadyne neutral electrodes allow for the cautery generator to show "ready" when the electrodes are not attached to the patient.This can allow the pad to not be attached to the patient fully and therefore not grounding the patient during a procedure and could cause harm.There is no patient injury reported.Device is available for return." further on we have been informed that "no patient consequence, no signs, symptoms or patient involvement." no further information was provided on the generator model, the generator settings and other further details that may have an influence on the investigation.
Additional Manufacturer Narrative
Retained samples of the concerned lot number have been inspected visually and tested electrically.Also, an adhesion test was performed.All tested electrodes were within limits; no failure could be detected.The involved device has not been made available to us.We have requested further information, a questionnaire to be completed and customer samples for testing but have received neither.The initial reporter has informed us on (b)(6) 2025: "the customer did not provide further details, also, the affected device was discarded and therefore cannot be analyzed, this complaint will be closed as a no product return".We therefore will also close out the investigation and the report.No conclusion can be drawn what might have caused the claimed incident.

• 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: 23664166
• Report Number: 8020045-2025-00026
• Device Sequence Number: 18710917
• Product Code: GEI
• UDI-Device Identifier: 39005531507778
• UDI-Public: (01)39005531507778
• 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): 12/11/2025

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: RS271A30
• Device Catalogue Number: 0855C
• Device Lot Number: 250129-2403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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