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

Model Number RSW213

Device Problem No Apparent Adverse Event (3189)

Patient Problem Burn(s) (1757)

Event Date 02/19/2024

Event Type  Injury  

Event Description

On march 20th, 2024, we have been informed about an incident involving a dispersive electrode at hospital (b)(6).A monitoring dispersive electrode [split electrosurgical neutral electrode] skintact model rsw213 and an erbe vio 3 generator have been used.Erbe informed leonhard lang about a burn on (b)(6) 2024.Erbe received this complaint in france because the operation was carried out with a erbe device.Since the electrode involved is a skintact rsw213, erbe informed leonhard lang.Additionally we have received two pictures showing a skin injury and a partially filled in erbe questionnaire.In the pictures a skin injury is seen that has the outer shape of the neutral electrode and the injury has occurred nearly around the entire electrode (conductive area) edge.We have requested further information on the patient, the skin preparation, the activation cycles, the used energy and how the skin injury have to be treated afterwards.No further details have been disclosed so far.

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.To the date of this report the involved device has not been made available to us.Currently no conclusion can be drawn what might have caused the skin injury.We have requested further information and will relay any further information and conclusion in a follow up report.

• 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: 19124142
• MDR Text Key: 340449913
• Report Number: 8020045-2024-00008
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 19005531504312
• UDI-Public: (01)19005531504312
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RSW213
• Device Lot Number: 231127-0806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2023
• 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