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	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient received a burn from the grounding pads during a genicular rf procedure.It was noted that the burn was first degree outer edges and second degree with yellow slough in the center.The patient was brought to emergency room to treat the burn.The patient was discharged and was prescribed silvadene dressing treatments.
Additional Manufacturer Narrative
Dgp-pm2-25 ln: 40024.The returned grounding pad was analyzed and passed visual inspection.However, it was not specified whether the area where the grounding pad was placed was shaved and clear of any lotion or cream.Thus, the application site was likely not prepared correctly prior to application.
Event or Problem Description
It was reported that the patient received a burn from the grounding pads during a genicular rf procedure.It was noted that the burn was first degree outer edges and second degree with yellow slough in the center.The patient was brought to emergency room to treat the burn.The patient was discharged and was prescribed silvadene dressing treatments.
Additional Manufacturer Narrative
This 3500a mdr was submitted in error.The regulatory reporting for this device is the responsibility of the manufacturer (nissha medical technologies ltd.) and not boston scientific.Therefore, please note that this event should not have been reported on a 3500a mdr form by boston scientific.
Event or Problem Description
It was reported that the patient received a burn from the grounding pads during a genicular rf procedure.It was noted that the burn was first degree outer edges and second degree with yellow slough in the center.The patient was brought to emergency room to treat the burn.The patient was discharged and was prescribed silvadene dressing treatments.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton DE TQ4 7 HP; UK TQ4 7HP
• 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: 15571352
• Report Number: 3006630150-2022-05345
• Device Sequence Number: 20378571
• Product Code: GEI
• UDI-Device Identifier: 35060441917622
• UDI-Public: 35060441917622
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 09/16/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/14/2023
• Device Model Number: DGP-PM2-25
• Device Catalogue Number: DGP-PM2-25
• Device Lot Number: 40024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 09/12/2024
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/24/2022; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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 Age: 73 YR
• Patient Sex: Female