MAUDE Adverse Event Report: NISSHA MEDICAL TECHNOLOGIES LIMITED BOSTON SCIENTIFIC; NEUTRAL ELECTRODES

Model Number	DGP-PMC2
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the account reached out to let rep know that they had an rf burn on a patient on (b)(6) 2025.The patient was a male and was not shaved where the grounding pad was placed.Patient was prescribed silvadine to help with burn.
Additional Manufacturer Narrative
A device history review has been carried out with all relevant manufacturing records retrieved from the archive and reviewed.This review identified no issues that could have impacted product quality.There have been no issues or confirmed complaints against this raw material or finished good lot.From the information received it would appear that patient preparation was not carried out in accordance with the ifu.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: NEUTRAL ELECTRODES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LIMITED; 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: 22961926
• Report Number: 3008933393-2025-00003
• Device Sequence Number: 18207723
• Product Code: GEI
• UDI-Device Identifier: 15060441917635
• UDI-Public: (01)15060441917635
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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 Expiration Date: 05/12/2026
• Device Model Number: DGP-PMC2
• Device Catalogue Number: 4012998C
• Device Lot Number: 84252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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: Male