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

Model Number	DGP-PM2-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient was burned on the left posterior thigh during a lumbar radiofrequency ablation procedure.
Additional Manufacturer Narrative
Correction to initial mdr.The suspect medical device in this mdr form is the reporting responsibility of nissha medical technologies ltd.And should not have been reported on a 3500a mdr form by boston scientific.
Event or Problem Description
It was reported that the patient was burn on the left posterior thigh during a lumbar radiofrequency ablation procedure.

• Brand Name: BOSTON SCIENTIFIC
• 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, dv TQ4 7 HP; UK TQ4 7HP
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19726319
• Report Number: 3006630150-2024-04474
• Device Sequence Number: 8191164
• Product Code: GEI
• UDI-Device Identifier: 35060441917622
• UDI-Public: 35060441917622
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: Lay User/Patient
• Device Expiration Date: 06/26/2025
• Device Model Number: DGP-PM2-25
• Device Catalogue Number: DGP-PM2-25
• Device Lot Number: 73583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/05/2024
• Date Device Manufactured: 06/27/2023
• 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 Age: 45 YR
• Patient Sex: Unknown