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

Model Number	XL31A/1
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 prewired dispersive electrodes of comparable design in the us (under k063161).Reviewing the sold amount of dispersive electrodes we have marketed 12,4 million prewired dispersive electrodes in the last 3 years globally (february 01, 2018 till today), and have had no similar complaint about a missing cable insulation during this time.We therefore, conclude that this failure is a singular error.Nevertheless, the ifu advises the user to check the product for damages and not to use a damaged product.We close the investigation.
Event or Problem Description
On september 24th, 2020 we have been informed about a product problem involving a dispersive electrode at an unknown hospital.A monitoring dispersive electrode erbe nessy plate 170 (model xl31a/1) and an unknown generator were used.The initial reporter stated that upon opening the package it was found that the insulation around rivet and cable terminal was missing.This can lead to burns during the application with a very high probability.No further information was provided to us.

• Brand Name: ERBE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10709973
• Report Number: 8020045-2020-00024
• Device Sequence Number: 3058751
• Product Code: GEI
• UDI-Device Identifier: 04050147015524
• UDI-Public: (01)04050147015524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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: 09/24/2021
• Device Model Number: XL31A/1
• Device Catalogue Number: NESSY PLATE 170
• Device Lot Number: 180924-2401
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other