MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LTD NEUT. ELECT, SELF-ADHESIVE; GENERATOR, LESION, RADIOFREQUENCY

Catalog Number	0406-650-205
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ablation procedure, the patient sustained several small burns and a second degree burn to the calf where the grounding pad was placed.It was reported the patient required a skin graft to repair the burns.At this time we are working with the sales representative and customer to obtain additional information on this case.
Event or Problem Description
It was originally reported that during an ablation procedure, the patient sustained several small burns and a second degree burn to the calf where the grounding pad was placed.It was reported the patient required a skin graft to repair the burns.Upon further investigation and customer feedback, it was determined that this product was not involved in the reported event.
Additional Manufacturer Narrative
Correction: upon further investigation and customer feedback, it was determined that this product was not involved in the reported event.

• Brand Name: NEUT. ELECT, SELF-ADHESIVE
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton TQ4 7 HP; UK TQ4 7HP
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20109226
• Report Number: 3015967359-2024-01755
• Device Sequence Number: 8571643
• Product Code: GEI
• UDI-Device Identifier: 07613327374612
• UDI-Public: (01)07613327374612(17)260320(10)9545146
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0406-650-205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/29/2024
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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