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

Model Number 4777-5

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 02/09/2021

Event Type  Injury  

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 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NIKOMED USA INC; 2800 turnpike drive; hatboro PA 19040
• Manufacturer (Section G): NIKOMED USA; 2800 turnpike drive ste 1; hatboro PA 19040
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11422977
• MDR Text Key: 234974435
• Report Number: 3006630150-2021-00766
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 40853512006224
• UDI-Public: 40853512006224
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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): Other