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	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient had a burn from the grounding pads.
Event or Problem Description
It was reported that the patient had a burn from the grounding pads.Additional information was received that the patient had a burn at the right abdomen.The grounding pads will not be returned.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton ID ; UK
• Manufacturer (Section G): CEA MEDICAL MANUFACTURING INC; 1735 merchants court; colorado springs CO 80916
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16088569
• Report Number: 3006630150-2022-07442
• Device Sequence Number: 6733464
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: Lay User/Patient
• Device Expiration Date: 08/09/2024
• Device Model Number: DGP-PM2-25
• Device Catalogue Number: DGP-PM2-25
• Device Lot Number: 51777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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