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	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a burn under the grounding pad on the right lateral flank after the procedure was completed.It was noted that the grounding pad was placed on an area with no hair and it was unclear if the patient had lotion on the skin.The patient was referred to wound care.
Additional Manufacturer Narrative
Dgp-pm2-25 (ln 39663).The returned grounding pad passed visual inspection and revealed no anomalies.
Event or Problem Description
It was reported that the patient experienced a burn under the grounding pad on the right lateral flank after the procedure was completed.It was noted that the grounding pad was placed on an area with no hair and it was unclear if the patient had lotion on the skin.The patient was referred to wound care.

• Brand Name: BOSTON SCIENTIFIC
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NISSHA MEDICAL TECHNOLOGIES LTD; torbay business park; woodview road; paignton 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: 15225962
• Report Number: 3006630150-2022-03961
• Device Sequence Number: 5633409
• Product Code: GEI
• UDI-Device Identifier: 35060441917622
• UDI-Public: 35060441917622
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/28/2022

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: 04/28/2023
• Device Model Number: DGP-PM2-25
• Device Catalogue Number: DGP-PM2-25
• Device Lot Number: 39663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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: 36 YR
• Patient Sex: Male