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

Model Number DGP-PMC2-5

Device Problem Defective Device (2588)

Patient Problem Burn(s) (1757)

Event Date 01/18/2022

Event Type  Injury  

Event Description

It was reported that a patient that had burn marks where the pad was placed.

Event 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.

• Type of Device: 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
• MDR Text Key: 285320719
• Report Number: 3006630150-2022-00403
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 35060441917639
• UDI-Public: 35060441917639
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention