MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LTD NEUT. ELECT, SELF-ADHESIVE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0406-650-205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was incorrectly reported as a manufacturer report on may 30, 2023, under manufacturer report number 3015967359-2023-01202.H3 other text : discarded by customer.
Event or Problem Description
It was reported that the patient completed a rf lumbar ablation and called the following week stating he had sustained a burn on his hip.The patient stated the burn started right after his procedure.The patient went to a clinic and was treated with antibiotics for what the patient said was a 3rd degree burn.It should be noted that the customer stated there were no issues in the or and no one remembers any alarms during the procedure.The procedure was completed successfully with no delays.
Additional Manufacturer Narrative
This event was incorrectly reported as a manufacturer report on may 30, 2023, under manufacturer report number 3015967359-2023-01202.Additional information, quality investigation complete.H3 other text : discarded by customer.
Event or Problem Description
It was reported that the patient completed a rf lumbar ablation and called the following week stating he had sustained a burn on his hip.The patient stated the burn started right after his procedure.The patient went to a clinic and was treated with antibiotics for what the patient said was a 3rd degree burn.It should be noted that the customer stated there were no issues in the or and no one remembers any alarms during the procedure.The procedure was completed successfully with no delays.

• Brand Name: NEUT. ELECT, SELF-ADHESIVE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17022183
• Report Number: 3015967359-2023-01207
• Device Sequence Number: 17860657
• Product Code: GEI
• UDI-Device Identifier: 35060842920023
• UDI-Public: 35060842920023
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023
• Report Date (Section F): 05/08/2023

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 Catalogue Number: 0406-650-205
• Device Lot Number: 68964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2023
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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