MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LTD BOSTON SCIENTIFIC; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	DGP-PM2-5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a radio frequency (rf) ablation procedure, the patient experienced first to second degree burns on the right upper thigh.
Additional Manufacturer Narrative
Correction to the initial mdr.This 3500a mdr was submitted in error.The regulatory reporting for this device is the responsibility of the manufacturer (nissha medical technologies ltd.) and not boston scientific.Therefore, please note that this event should not have been reported on a 3500a mdr form by boston scientific.
Event or Problem Description
It was reported that during a radio frequency (rf) ablation procedure, the patient experienced first to second degree burns on the right upper thigh.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton CA ; UK
• Manufacturer (Section G): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton, dv ; UK
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18769301
• Report Number: 3006630150-2024-00924
• Device Sequence Number: 7355863
• Product Code: GEI
• UDI-Device Identifier: 35060441917615
• UDI-Public: 35060441917615
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/10/2025
• Device Model Number: DGP-PM2-5
• Device Catalogue Number: DGP-PM2-5
• Device Lot Number: 73571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• 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