MAUDE Adverse Event Report: NAKANISHI INC. NSK VARIOS LUX; DENTAL SCALER HANDPIECE

Model Number VA-LUX-HP

Device Problem Unintended Electrical Shock (4018)

Patient Problem Numbness (2415)

Event Date 08/12/2022

Event Type  Injury  

Event Description

Received a report from the hygienist at the location that their patient had received an electric shock from their electric scaler.Patient described intense pain when the foot pedal was activated to begin the cleaning procedure.The scaling tip had not yet contacted the buccal surface of #18 tooth when the patient stopped the hygienist complaining of intense pain.The hygienist stopped and talked with the patient letting them know that the scaling tip had not even contacted his tooth only the water coming from the tip.After waiting for a few minutes, the patient recovered.The hygienist turned the scaling unit off, unplugged it, and then plugged the unit back in and turned it on again.After a discussion with the patient about how strange the situation was and restating that the scaler had not even contacted his tooth only the water, the hygienist and patient agreed to continue the procedure.Once the hygienist pressed the foot pedal to begin the procedure the water started and before the scaler tip contacted the tooth the patient claimed again to have felt an electric shock.It was at that time that the hygienist put the unit out of service and the procedure was finished manually.Patient has reported to the doctor to have experienced ongoing pain and numbness near the affected area.The latest report from the patient stated that the pain was subsiding but still has a numb/deadened strip from the tip to the back of their tongue although this does not seem to have any effect on their sense of taste.On (b)(6) 2022 nsk america received fda notification of a voluntary report made by a patient for a similar case (reference mdr report# mw5111578) it was determined through our investigation that the voluntary report made by the patient (mw5111578) were for the same event.This was confirmed by the doctor.The device model in the voluntary report made by the patient (varios 370) was found to be incorrect the unit is in fact a varios 350.

• Brand Name: NSK VARIOS LUX
• Type of Device: DENTAL SCALER HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 15433165
• MDR Text Key: 300035011
• Report Number: 1422375-2022-00036
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2022,08/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VA-LUX-HP
• Device Catalogue Number: E250050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2022
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White