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

Model Number WR21

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 03/01/2024

Event Type  Injury  

Event Description

On march 18th, 2024, we have been informed about an incident involving a monitoring dispersive electrode at (b)(6).Quirofano 15 ( orl) primera planta.A monitoring dispersive electrode [split electrosurgical neutral electrode] skintact model wr21 and a erbe icc300 generator have been used.The initial report stated that [translated from spanish to german to english language]: there was an incident with the neutral electrode that caused a patient skin burn.This was caused by the heating of the neutral electrode used during the procedure.We have a sample, but the lot number could not be determined." our customer has limited the concerned lot number to two possible lot numbers the customer had received.These are 231114-0803 and 231123-0804.We received also two pictures showing the involved dispersive electrode front [gel] side.The front gel side of the involved dispersive electrode is showing a burnt area opposite the connecting tab.On march 22nd, 2024, we received a filled in questionaire in spanish language.The questionaire [translated from spanish to german to english language] states that the patient body type was slim and the skin type was described as dry skin and little hair.A 2 hours left cervicotomy was performed.The patient was lying in supine decubitus positon and was not repositioned.The patient's body temperature was managed during surgery by a heat blanket.The patient skin was not shaven, not dried, not cleaned prior application and no ointment has been applied prior application.The monitoring dispersive electrode was placed on the left thigh, not repositioned and didn't lift up during surgery.It was also specified that some hair was present in the burned area of the monitoring dispersive electrode.It was specified that the patient burn was discovered underneath the monitoring dispersive electrode.The burn was detected after the procedure.The patient burn was specified as nectrotic area of 1cm x 1cm.The size was described as circular lesion, central area necrotic, white periphery.The electrode was covered by a heat blanket on the patient and it was described to be as heat source in the immediate vicinity of the neutral electrode.The patient burn was treated with "silvederma".We assume according to the burnt residues seen on the picture that at least a 3rd degree burn must have happened.The power settings have been disclosed as "auto cut 20 maxw" and "auto coag 20 maxw".No further details have been disclosed so far.

Manufacturer Narrative

Retained samples of the concerned lot numbers have been inspected visually and tested electrically.Mechanical tests were performed on 3 retained samples each lot number.All tested samples were found to perform within limits.No faults were detected.On april 03rd, 2024, the involved device was received in a transparent pe pouch.A burnt spot can be recognized opposite the connecting tab.The burnt spot is about 1x1cm in size and shows patient hair inside the spot and around it.Judging the burnt spot we assume at least a 3rd degree burn must have happened.Due to the burn residues in the gel an electrical test or an adhesive strength test of the involved sample was not possible.The ifu explicitly states: "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.Remove any hair from the chosen skin area and clean it carefully, e.G.Of cosmetics.Carefully dry the area, especially if alcohol or other skin cleaning agents have been used.Avoid using flammable skin prepping agents or disinfectants, e.G.Acetone degreasers.Be aware that failure to shave the area may lead to burns.Selection and preparation of the placement site make sure that the selected site is not thermally insulated or subject to additional heat from heat sources during the operation." further on the ifu states to the placement site: "selection and preparation of the placement site - select a convex skin surface that is muscular or well supplied with blood and as close as possible to the surgical site, but if possible at least 15 cm away from it." it is unclear whether the ifu has been followed regarding the activation cycles.The ifu states "before using the electrosurgical device, familiarize yourself with its instructions for use, in particular with respect to power setting restrictions and the maximum uninterrupted activation period, as well as information on the use of neutral electrodes for applications with a high energy output.Product limitations for universal neutral electrodes restrict the duration of activation to a maximum of 60 seconds within each 2 minute period." however, based on the information provided to us we can determine that a user-error has contributed to or caused the claimed incident in 3 respects.Not shaving the placement site, thermally straining the monitoring dispersive electrode with a heat blanket and the operation field was on the neck and the dispersive electrode was not placed as close as possible when placed the dispersive monitoring electrode on the left thigh.We therefore consider the investigation and the report closed.

• 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: 19114411
• MDR Text Key: 340237857
• Report Number: 8020045-2024-00007
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 19005531505930
• UDI-Public: (01)19005531505930
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K063161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/16/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: WR21
• Device Lot Number: 231114-0803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 50 KG