MAUDE Adverse Event Report: NIKOMED USA INC NIKOSURG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	4777-5
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: 4777-5, serial/lot: (b)(4), description: neutral electrode, w/cable 5pk.
Event or Problem Description
It was reported that the patient experienced slight pain and a burning sensation when two grounding pads were applied.The physician offered treatment to the patient but it was declined.The patient is healing well.

• Brand Name: NIKOSURG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NIKOMED USA INC; 2800 turnpike drive; hatboro PA 19040
• MDR Report Key: 11422977
• Report Number: 3006630150-2021-00766
• Device Sequence Number: 4076085
• Product Code: GEI
• UDI-Device Identifier: 40853512006224
• UDI-Public: 40853512006224
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 07/30/2022
• Device Model Number: 4777-5
• Device Catalogue Number: 4777-5
• Device Lot Number: 810720011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other