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

Model Number	DGP-PMC2-5
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient that had burn marks where the pad was placed.
Event or Problem Description
It was reported that a patient that had burn marks where the pad was placed.Additional information was received that the grounding pad was positioned at the patients calf where it was hairy.No injuries were noted prior to the burns.The skin was discolored and tender from burns.

• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; 814 airport way; woodview road; sandpoint ID 83864
• Manufacturer (Section G): CEA MEDICAL MANUFACTURING INC; 1735 merchants court; colorado springs CO 80916
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13494944
• Report Number: 3006630150-2022-00403
• Device Sequence Number: 4253637
• Product Code: GEI
• UDI-Device Identifier: 35060441917639
• UDI-Public: 35060441917639
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: 05/19/2023
• Device Model Number: DGP-PMC2-5
• Device Catalogue Number: DGP-PMC2-5
• Device Lot Number: 34300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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