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

Model Number	RS271A30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional 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.The involved device has not been made available to us for a further investigation.We received a picture showing a small burnt spot on the left side near to the isolated connecting tab when viewed on the gel side of the electrode.However, the information provided indicates that the ifu has not been followed.The ifu explicetly states: "these neutral electrodes must only be used by appropriately qualified medical personnel who have been trained in their use based on these instructions for use.(.) 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.(.) monitoring electrodes or other devices that may provide an alternative earthing route for the high-frequency current should be applied as far from the surgical site as possible." the staff member removed a pad and was about to replace it.While she was holding the pad, the surgeon activated the generator.The staff member's body thus created an alternative earthing route for the high-frequency current causing a burn on her fingers.We therefore conclude that a user error caused the event.
Event or Problem Description
On (b)(6) 2021 we have been informed about an incident involving a dispersive electrode.A neurosurgery procedure was performed at winchester medical centerl in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The user report stated: " it was reported by the sales rep that during a neurology case while using two 0855c pads with two generators one of the pads alarmed as if it was not in good contact with the patient.The or staff removed pad and was about to replace the pad and the generator was not shut off, while holding it the surgeon activated the generator resulting in three small burns on her fingers" the injury was described as small burn.We have also been informed that there are no anticipated long-term effects from the burn and the current status of the staff member is that the injuries are doing fine and burn healed.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 11839773
• Report Number: 8020045-2021-00016
• Device Sequence Number: 17059086
• Product Code: GEI
• UDI-Device Identifier: 39005531507778
• UDI-Public: (01)39005531507778
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: RS271A30
• Device Catalogue Number: 0855C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other