MAUDE Adverse Event Report: LEONHARD LANG GMBH ERBE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	XL31A
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are reporting this incident because we distribute prewired dispersive electrodes of comparable design in the us (under k030362).Retained samples of the same lot have been inspected visually.No faults were detected.On february 12th, 2025, we have received the concerned device for further investigation.The visual investigation has shown that one side of the conductive aluminum was bent in the area of the connecting tab and therefore both conductive aluminium areas have been riveted at one side to the ring terminal of the cable.On the other side of the split electrode the bent aluminum was also touching the second rivet of the cable ring terminal.A connection of both conductive aluminum resulted, effectively shorting them out.The connection of both conductive aluminum sides have caused the generator to recognize the split monitoring dispersive electrode as an unsplit nonmonitoring electrode.We assume that a defective dispersive electrode, which was not sorted out in the manufacturing process, was riveted.During the subsequent manual assembly of the foam insulation it was not discovered that one end of the cable was not correctly fixed to the electrode.We consider this a freak escape.We conclude a manufacturing problem led to the incident.We consider the investigation closed.
Event or Problem Description
On january 30th, 2025 we have been informed about a malfunction involving a monitoring dispersive electrode at an unknown hospital.A monitoring dispersive electrode erbe nessy plate 170 (model xl31a) and an unknown generator were used.The initial report stated that [translated from german to english language]: "customers noticed: ne [monitoring dispersive electrode] is in two parts, but is recognized by the device as one part.Can be reproduced on hf device [generator].(.) insulation around electrode connecting tab removed for analysis purposes.Conacting tab of one side of the conductive [aluminum] material is bent in contact surface [electrode connecting tab] and is also connected to the other side of the conductive [aluminum] material by a crimp contact.(short circuit)".No further details have been disclosed.

• Brand Name: ERBE
• 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: 21394991
• Report Number: 8020045-2025-00003
• Device Sequence Number: 8292148
• Product Code: GEI
• UDI-Device Identifier: 04050147005167
• UDI-Public: (01)04050147005167
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: XL31A
• Device Catalogue Number: NESSY PLATE 170
• Device Lot Number: 240724-2401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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