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

Model Number	XL31A
Medical Device Problem Codes	No Apparent Adverse Event (3189); Component Misassembled (4004)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On august 23st, 2024, we have been informed about an incident involving a dispersive electrode at unknown user facility.A monitoring dispersive electrode erbe nessy®plate 170 zweiteilig (model xl31a) and an unkwnown generator have been used.The initial reporter stated that [translated from german language to english language] "the insulation is missing at the nessy connection.The cable connections are exposed!" no further details have been disclosed so far despite further requests.
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually.No faults were detected.The involved device has not been made available to us.We are reporting this incident because we distribute dispersive electrodes of comparable design in the us (under the 510k reference: k063161).No further details have been disclosed so far.We will provide a follow up report.
Event or Problem Description
On august 23 st, 2024, we have been informed about an incident involving a dispersive electrode at an unknown user facility.A monitoring dispersive electrode erbe nessy®plate 170 (model xl31a) and an unknown generator have been used.The initial reporter stated that [translated from german language to english language] "the insulation is missing at the nessy connection.The cable connections are exposed!" we have received a picture showing the concerned customer sample showing that the rivet insulation on the neutral electrode neck of the attached cable is missing.No further details have been disclosed so far despite further requests.
Additional Manufacturer Narrative
Retained samples of the same lot have been inspected visually.No faults were detected.The visual investigation of the concerned customer sample has shown that the foam insulation of the cable riveting was missing.We assume that the failure was caused by an assembly employee.During the subsequent manual packaging of the assembled neutral electrodes it was not discovered that the foam insulation was missing.The ifu contains a mitigating warning: "this product may be used only by trained medical staff, who have been shown how to use it according to the instructions for use.Check the product before use for external damage! never use damaged return electrodes, cables or plugs." we have reviewed our complaint database.During the last 5 years we have one similar complaint recorded.Therefore it was assessed to initiate a capa introducing further actions to avoid the claimed error in the future.We therefore close the investigation.

• Brand Name: ERBE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 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: 20272494
• Report Number: 8020045-2024-00019
• Device Sequence Number: 7419014
• Product Code: GEI
• UDI-Device Identifier: 04050147015524
• UDI-Public: (01)04050147015524
• 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): 10/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: XL31A
• Device Catalogue Number: NESSY PLATE 170
• Device Lot Number: 231204-2403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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