MAUDE Adverse Event Report: NSK AMERICA CORP. VARIOS ULTRASONIC SCALER; SCALER, ULTRASONIC

Model Number VARIOS 370

Device Problem Unintended Electrical Shock (4018)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 08/16/2022

Event Type  Injury  

Event Description

A painful electric shock was transmitted via the water spray of an nsk varios ultrasonic scaler.This happen twice to one patient and upon further questioning of the staff was found also to have occurred four months prior to another patient.The after effects of the shock persisted four more than three hours after the event, affecting taste and sensation throughout the regions of the mouth struck by the discharge.Fda safety report id # (b)(4).

• Brand Name: VARIOS ULTRASONIC SCALER
• Type of Device: SCALER, ULTRASONIC
• Manufacturer (Section D): NSK AMERICA CORP.
• MDR Report Key: 15258103
• MDR Text Key: 298398022
• Report Number: MW5111578
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/16/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VARIOS 370
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2022
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White