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	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As neither a lot number nor involved samples have been made available to the date of this report no investigation could be performed.The incident is reported because it is unknown whether it has to be treated to avoid permanent damage to a body structure.The incident might not constitute a reportable event.As the initial reporter has specified that: "i certify that all information that are known/available has been disclosed.".We therefore will close out the investigation and the report.No conclusion can be drawn what might have caused the claimed incident.
Event or Problem Description
On (b)(6) 2024 we have been informed of an incident involving dispersive electrodes.A heart ablation procedure was performed at cox health systems (b)(6) hospital, (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 that heart ablation in the cath lab.Using 0855c as grounding pad.Post op a pad site burn was reported.Surgical delay was unknown.Device is not returning.I certify that all information that are known/available has been disclosed." the event date was specified as "unk/unk/2025" and the procedure date as " (b)(6) 2025" no further information was provided on the body type/weight of the patient, patient skin, whether the placement site was prepped, the orientation of the dispersive electrode relative to the surgical area, the duration of the procedure.

• 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: 22780365
• Report Number: 8020045-2025-00020
• Device Sequence Number: 13217269
• 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
• Report Date (Section B): 08/11/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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