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)
Date of Event	10/31/2023
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.Currently no conclusion can be drawn what might have caused the incident.However we will repeat requesting further information and the involved sample and will relay any in a follow up report.
Event or Problem Description
On (b)(6), 2023 we have been informed about an incident involving a dispersive electrode.A tilf procedure was performed at (b)(6) hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unkown generator had been used.The initial report was stating that "sales rep reported electrode alarm error occurred multiple times on efu during a tilf procedure.Or staff checked device to confirm placement of 0855c.At the end when surgical drapes were removed, small burn was discovered 2-3 millimeters right above patients crevice of patients buttocks.The staff covered the small burn with steri strip.After noticing burn, staff checked drapes for burn/hole and none were discovered." no further information was provided on the body type/weight of the patient, whether the placement site was prepped, the precise position and 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.After repeated requests for further information and samples for testing we have been informed on december 11th, 2023 that: "at this date no information has been provided, this file will be close[d] (.)" no conclusion can be drawn what might have caused the incident.We therefore close the investigation and the report.
Event or Problem Description
On (b)(6) 2023 we have been informed about an incident involving a dispersive electrode.A tilf procedure was performed at uchealth poudre valley hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unkown generator had been used.The initial report was stating that "sales rep reported electrode alarm error occurred multiple times on efu during a tilf procedure.Or staff checked device to confirm placement of 0855c.At the end when surgical drapes were removed, small burn was discovered 2-3 millimeters right above patients crevice of patients buttocks.The staff covered the small burn with steri strip.After noticing burn, staff checked drapes for burn/hole and none were discovered." no further information was provided on the body type/weight of the patient, whether the placement site was prepped, the precise position and 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: 18235698
• Report Number: 8020045-2023-00027
• Device Sequence Number: 6936604
• 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): 12/14/2023

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
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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