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 incident is reported because it is unknown if an injury exists and whether such injury had to be treated.The incident might not constitute a reportable event.We have requested further information, a questionaire to be completed and customer samples for testing but have received neither so far.We will provide a follow up report once we have received any additional information.
Event or Problem Description
On (b)(6) 2024 we have been informed about an incident involving a dispersive electrode.A "total hip replacement" procedure was performed at (b)(6) hospital llc, (b)(6) texas.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 the sales rep that during a total hip replacement, the patient had an icd and they used a megadyne sticky pad and they put the pad on the left shoulder and the icd was not turned off.The leads were later found to be burned.They do not know if the burns were from this surgery or not.Case was successfully completed.No device will be returned." the event date was specified as "01/unk/2024".No further information was provided on the body type/weight of the patient, whether the placement site was prepped, the orientation of the dispersive electrode relative to the surgical area, the duration of the procedure and the activation cycle 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 incident is reported because it is unknown if an injury esists and whether such injury had to be treated.The incident might not constitute a reportable event.We have requested further information, a questionaire to be completed and customer samples for testing but have received neither.The initial reporter has informed us on april 2nd, 2024: "as no further information has been available at this time, the complaint is now at closed status".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 february 15th, 2024 we have been informed about an incident involving a dispersive electrode.A "total hip replacement" procedure was performed at (b)(6) hospital llc, amarillo, texas.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 the sales rep that during a total hip replacement, the patient had an icd and they used a megadyne sticky pad and they put the pad on the left shoulder and the icd was not turned off.The leads were later found to be burned.They do not know if the burns were from this surgery or not.Case was successfully completed.No device will be returned." the event date was specified as "01/unk/2024" no further information was provided on the body type/weight of the patient, whether the placement site was prepped, the orientation of the dispersive electrode relative to the surgical area, the duration of the procedure and the activation cycle 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: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 18892494
• Report Number: 8020045-2024-00003
• Device Sequence Number: 7598274
• 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): 04/08/2024

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: 02/15/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/08/2024
• 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