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

Model Number RS05

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

On march 05th, 2024 we have been informed about an incident involving a dispersive electrode.A prosthesis implantation with lipo abdomen procedure was performed at an unknown hospital in brazil.A none monitoring dispersive electrode (model skintact rs05) and an unknown generator have been used.The initial reporter stated "the patient was undergoing a prosthesis implantation with lipo abdomen, when removing the earth plate [none monitoring dispersive electrode], a 3rd degree burn was found.It was evaluated by the patient`s doctor and a curement was performed." no information about the generator model, the power settings, the patient, how the skin was prepared and how the injury was treated afterwards have been disclosed to us.

Manufacturer Narrative

Retained samples of the same lot have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults were detected.The involved device has not been made available to us.We have requested additional information and our customer informed us that "we know that this information would be of great value for your investigation of this case, but as you read the reminder in my last email, the complaint is sent anonymously to the anvisa website, and we have to respond as much as possible with the information given to us.(.) notivisa is a platform by brazil's ministry of health that allow customers to report possible quality-deviations anonymously.In such cases we are not able to request additional information, photos, or samples to customers." however the ifu states a warning: "improper use of neutral electrodes can cause damage to tissue.These instructions for use serve to ensure patient safety.Not following these instructions may lead to burns, pressure necroses, or other skin trauma during use.(.) if an electrosurgical unit offers a neutral electrode contact quality monitoring system always use a split electrode.(.) in any case, the split neutral electrodes are compatible with the dynamic contact quality monitoring systems rem¿, nessy ®, and arm¿".We do not know if the used generator was equipped with such a cqms system to prevent with a split monitoring electrode such a patient injury.As no further information was available, no conclusion can be drawn what might have caused the claimed incident.We therefore close the investigation.

• Brand Name: SKINTACT
• Type of Device: 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: 18947976
• MDR Text Key: 338183597
• Report Number: 8020045-2024-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 19005531502981
• UDI-Public: (01)19005531502981
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K063161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RS05
• Device Lot Number: 220503-0821
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other