MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES STYKER; NEUTRAL ELECTRODE

Model Number	0406-650-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information requested from manufacturer about the event.No further detail has been provided.No lot number was indicated within the complaint therefore a review of manufacturing records cannot be performed.No further action required at this time.
Event or Problem Description
It was reported that the patient had pain by the grounding pad during the rfa and sustained a 2-3 degree burn that was under the grounding pad and discovered after the procedure.The patient sustained a 2-3 degree clover shaped burn that required wound care for weeks afterwards to optimize healing and reduce scarring and chronic pain.

• Brand Name: STYKER
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES; torbay business park; woodview rd; paignton,, devon TQ4 T HP; UK TQ4 THP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LIMITED; torbay business park; woodview rd; paignton, devon TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: juliana scotto di carlo ; 400 exchange street; buffalo, NY 14204 ; 7168496419
• MDR Report Key: 21763747
• Report Number: 3008933393-2025-00001
• Device Sequence Number: 8738506
• Product Code: GEI
• UDI-Device Identifier: 15060842920029
• UDI-Public: 15060842920029
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K203494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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 Model Number: 0406-650-205
• Device Catalogue Number: 700000856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown