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	11/27/2023
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.After repeated requests for further information and samples for testing we have been informed "i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst".Further on it was stated that "the investigation has been completed based on the information provided to date." no conclusion can be drawn what might have caused the claimed incident.We therefore close the investigation and the report.
Event or Problem Description
On (b)(6), 2024 we have been informed about an incident involving a dispersive electrode.A "robotic asst total laparoscopic hysterectomy with bso" procedure was performed at (b)(6)hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an erbe generator (model unknown) had been used.The initial report was stating that "sales rep reported from the customer that on (b)(6) 2023, dr (b)(6) was performing a robotic asst total laparoscopic hysterectomy with bso.When the procedure was over and the patient was undraped, the staff noticed a burn where the disposable return electrode (0855c) had been placed on the patient's right upper thigh.The burn was described as a full thickness burn approximately 2.5cm x 2.0cm.The patient was instructed to apply bacitracin ointment daily.The cautery pencil and disposable return electrode were plugged into the erbe esu (on the robotic tower) with settings of 3 & 3 on cut & coag respectively.The patient's hospital stay was not prolonged due to the burn.Device is not available for return." 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: 18612607
• Report Number: 8020045-2024-00001
• Device Sequence Number: 7444841
• 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): 01/31/2024

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: 01/05/2024
• Initial Report FDA Received Date: 01/31/2024
• 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: Required Intervention
• Patient Sex: Female