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

Model Number RS28

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Skin Inflammation/ Irritation (4545)

Event Date 03/29/2021

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 of the same lot.All tested samples were found to perform within limits.No faults were detected.Neither a picture of the involved device nor the involved device itself has been made available to us for further investigation.We have repeatedly requested for additional information and our customer informed us that no further information will be available.As no further information was made available despite of repeated requests, no conclusion can be drawn what might have caused the incident.We therefore close the investigation.

Event Description

On (b)(6) 2021 we have been informed about an incident involving a dispersive electrode.A two and a half hour breast surgery procedure was performed at an unknown hospital in (b)(6).A monitoring dispersive electrode (model skintact rs28) and a (b)(6) domestic generator were used.The initial reporter was providing the following information: "after surgery, nurse peel off the patient plate and found the redness and bruising." the injury was found on the right thigh.The patient was described as (b)(6) years old.It was also reported that "the user throw away the defective plate"."description of treatment: pharmacological treatment." we received a picture showing the injury taken on (b)(6).The picture is showing that the injury occured underneath the adhesive foam area.No information about the the power settings, activation cycles, the patient and how the skin was prepared have been disclosed to us.

• Brand Name: SOPHMED
• 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: 11804140
• MDR Text Key: 253829825
• Report Number: 8020045-2021-00014
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 39005531504352
• UDI-Public: (01)39005531504352
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K063161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2021

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 Expiration Date: 11/24/2022
• Device Model Number: RS28
• Device Catalogue Number: 2204
• Device Lot Number: 201124-0803
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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