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

Model Number RSW25/5

Device Problem Insufficient Information (3190)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Retained samples of the same lot have been inspected visually and electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults were detected.The involved devices have not been made available to us.No information on the patients, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use were provided.The incidents were reported because it is unknown if and how the skin injuries had to be treated afterwards.The incidents might not constitute reportable events.We have requested additional information and the initial reporter informed us that "i will attempt to trace back the incident forms for each incident to try and gain anymore information." we therefore will provide a follow up report with any additional information we will receive.

Event Description

On (b)(6) 2021 we have been informed about two incidents involving skintact dispersive electrode.An unknown procedure was performed at (b)(6) hospital in (b)(6).Monitoring dispersive electrodes (model skintact rsw25/5) and an unknown generator have been used.The initial report specified that: "we have had 2x incidents (.) in the last 2 weeks.We have experienced incidents of damage to patient's skin when removing the pad.(.) we are very careful about removing the pads gently from the skin." after several requests for further information we have been informed on (b)(6) that "both patients had elderly, dry skin.Skin was clean and dry when the electrode was attached and no extreme heat or moisture came into contact with the electrode during surgery.Both patients had no visible hair under the electrodes and both plates were removed slowly and gently.The most severe injury caused bleeding to the area around 10 minutes after removal of the pad but the other incident only caused the removal of the superficial layers of the skin under the glue.There were no blisters or burns to either patient." no information about the generator model, the power settings, the patient, how the skin was prepared and if and how the injury was treated afterwards have been disclosed to us.

Event Description

On (b)(6) 2021 we have been informed about two incidents involving skintact dispersive electrode.An unknown procedure was performed at (b)(6) hospital in uk.Monitoring dispersive electrodes (model skintact rsw25/5) and an unknown generator have been used.The initial report specified that: "we have had 2x incidents (.) in the last 2 weeks.We have experienced incidents of damage to patient's skin when removing the pad.(.) we are very careful about removing the pads gently from the skin." after several requests for further information we have been informed on july 2nd that "both patients had elderly, dry skin.Skin was clean and dry when the electrode was attached and no extreme heat or moisture came into contact with the electrode during surgery.Both patients had no visible hair under the electrodes and both plates were removed slowly and gently.The most severe injury caused bleeding to the area around 10 minutes after removal of the pad but the other incident only caused the removal of the superficial layers of the skin under the glue.There were no blisters or burns to either patient." no information about the generator model, the power settings, the patient, how the skin was prepared and if 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 electrically.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults were detected.On august 03rd, we have received one esu electrode from the same lot from the customer.The customer sample electrode was delivered in a not steam prove paper letter.The returned customer sample has been inspected visually and tested mechanically.The tested sample was found to perform within limits.No faults could be detected.The involved devices have not been made available to us.No information on the patients, whether any medication was being taken, which might have a skin weakening effect, duration of use and details of the use were provided.The incidents were reported because it is unknown if and how the skin injuries had to be treated afterwards.The incidents might not constitute reportable events.We have requested additional information and the initial reporter informed us that "i will attempt to trace back the incident forms for each incident to try and gain anymore information." after several requests for further information none have been made available to us.No conclusion can be drawn what might have caused the customer problems.We therefore consider the investigation closed.

• Brand Name: SKINTACT
• Type of Device: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 12116204
• MDR Text Key: 269779319
• Report Number: 8020045-2021-00019
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 19005531597550
• UDI-Public: (01)19005531597550
• Combination Product (y/n): N
• PMA/PMN Number: K063161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/27/2022
• Device Model Number: RSW25/5
• Device Lot Number: 190927-0803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other