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
As neither a lot number nor the involved sample have been made available to the date of this report no investigation could be performed.We have requested the involved device and also the concerned lot number from the initial reporter.Once any further information will become available we will provide a follow up report.
Event or Problem Description
On november 25th, 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 had been used.The initial report stated that [translated from german to english language]: "the electrode [monitoring dispersive electrode] malfunctioned.Our customer found the cause.See image.Please analyze the fault." we also have received a picture showing tha the cable ring eyelet of one aluminium area was not riveted and was only held in place by the adhesive foam insulation around the cable connecting area at the top side of the monitoring dispersive electrode.Because of this the cable terminal was so placed that it touched both aluminum areas and thus shorting them.No further details have been disclosed.
Event or Problem Description
On november 25th, 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 had been used.The initial report stated that [translated from german to english language]: "the electrode [monitoring dispersive electrode] malfunctioned.Our customer found the cause.See image.Please analyze the fault." we also have received a picture showing tha the cable ring eyelet of one aluminium area was not riveted and was only held in place by the adhesive foam insulation around the cable connecting area at the top side of the monitoring dispersive electrode.Because of this the cable terminal was so placed that it touched both aluminum areas and thus shorting them.We have requested the involved device and also the concerned lot number from the initial reporter and have been informed that "sorry the package was already discarded and so not sure the lot in this case.But according to our purchase data base it could be one of the lots below.Lot: 250606-2401, 250422-2403, 250512-2402, 250627-2404".No further details have been disclosed.
Additional Manufacturer Narrative
We are reporting this incident because we distribute prewired dispersive electrodes of comparable design in the us (under k030362).We have requested the involved device and also the concerned lot number from the initial reporter and have been informed that "sorry the package was already discarded and so not sure the lot in this case.But according to our purchase data base it could be one of the lots below.Lot: 250606-2401, 250422-2403, 250512-2402, 250627-2404".The manufacturing and device history records have been reviewed for all of the possible concerned lot numbers have been inspected.For two of the 4 possible conerned lot numbers a machine breakdown time was documented for the riveting machine.It is impossible to verify afterwards whether the reported defect can be traced back to a machine optimization and or machine adjustment of machine settings or a machine repair.A review of the internal deviations revealed that no back-inspection was carried out because no defective parts were discovered during production.Retained samples of the possible concerned lot numbers have been inspected visually.No faults were detected.We have received pictures showing the claimed failure.The visual investigation has shown that one cable ring terminal was not riveted to the aluminium foil in correct postion.The rivet was punched trough the foam and the alumium foil of the connecting tab without fixing the cable ring terminal.The cable ring terminal is located beneth and was only fixed by the stuck of the ahdesive foam cable insulation in place.As the cable ring terminal was located beneth it was touching therefore both aluminium foils.A connection of both split conductive aluminum foils resulted, effectively shorting them out.The connection of both conductive aluminum sides have caused the generator to detect a failure.Based on the generator's cqms (continuous quality management system), we assume that such a fault cannot lead to injury or endangerment of a patient, as the generator does not recognize the electrode as a split electrode.The origin of the defective electrode was caused in the manual cable manufacturing process of leonhard lang.During the subsequent manual assembly of the foam insulation it was not discovered that one cable ring terminal was not correctly riveted to the electrode.Based on the 100% visual inspection before applying the rivet insulation, we consider this a freak escape.We conclude a manufacturing single error problem led to the incident.We consider the investigation closed.

• 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: 23800458
• Report Number: 8020045-2025-00030
• Device Sequence Number: 7621686
• 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,Followup
• Report Date (Section B): 01/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: XL31A
• Device Catalogue Number: NESSY PLATE 170
• Device Lot Number: 250606-2401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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