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	Insufficient Information (4580)
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 so far.The incidents are reported because it is unknown whether they had to be treated to avoid permanent damage to a body structure.The incidents might not constitute reportable events.We have requested further information, a questionnaire to be completed and customer samples for testing but have received neither.We will provide a follow up report once we have received more information.
Event or Problem Description
On (b)(6) 2024 we have been informed about two incidents involving dispersive electrodes.A "cardiovascular 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 ": the account contact that post op two open heart procedures, when they get the patients out into icu to remove, they are having skin tears, no matter how careful they are with removing the product.Skin tears, patients having to be treated for wound.Caller did not know treatment at time of call." 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 patients, patient skin, if skin weakening medical substances have been used (e.G.Steroids), whether the placement sites were prepped, the orientation of the dispersive electrodea relative to the surgical area, the duration of the procedurea despite repeated requests.
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 so far.The incidents are reported because it is unknown whether they had to be treated to avoid permanent damage to a body structure.The incidents might not constitute reportable events.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: "per our procedure we only send 3 attempts, so we wont be getting no more information".We therefore will also 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 about two incidents involving dispersive electrodes.A "cardiovascular procedure" was performed at (b)(6), kentucky.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator had been used.The initial report was stating that ": (.) the account contact that post op two open heart procedures, when they get the patients out into icu to remove, they are having skin tears, no matter how careful they are with removing the product.Skin tears, patients having to be treated for wound.Caller did not know treatment at time of call." the event date was specified as "(b)(6)2025" and the procedure date as "(b)(6)2025".No further information was provided on the body type/weight of the patients, patient skin, if skin weakening medical substances have been used (e.G.Steroids), whether the placement sites were prepped, the orientation of the dispersive electrode relative to the surgical area, the duration of the procedure despite repeated requests.

• 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: 21352870
• Report Number: 8020045-2025-00002
• Device Sequence Number: 7959228
• 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): 02/24/2025

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: 01/16/2025
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 02/25/2025
• 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: Required Intervention
• Patient Sex: Unknown