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
Event or Problem Description
On (b)(6) 2023, we have been informed about an incident involving a 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]: "the cover that should be on the connector is missing.It is a complaint from an end user." on (b)(6) 2023 we have received 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.
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.The concerned device was disinfected before investigation.The visual investigation 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 producted more than 20 million pcs of prewired dispersive electrodes and no similar complaint was recorded.The incident was therefore assessed to be a single error and no further actions will be carried out so far.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: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 16500814
• Report Number: 8020045-2023-00004
• Device Sequence Number: 17674468
• 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
• Report Date (Section B): 03/08/2023

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 Expiration Date: 06/17/2025
• Device Model Number: XL31A
• Device Catalogue Number: NESSY PLATE 170
• Device Lot Number: 220617-2403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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