MAUDE Adverse Event Report: NAKANISHI INC. NSK; DENTAL HANDPIECE COUPLER

Model Number KCL-LED

Device Problem Unintended Electrical Shock (4018)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Nsk america received a report from one of our distributors in (b)(4) that their customer had reported that patients were being shocked by two of their handpiece couplers.After several attempts nsk america has not been able to confirm the adverse event or any injury with the end user.A follow up report will be made once confirmation is made or further details become available.Both devices have been returned from the distributor in (b)(4) and forwarded to manufacturer for investigation.This is device report 1 of 2.

• Brand Name: NSK
• Type of Device: DENTAL HANDPIECE COUPLER
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 15601326
• MDR Text Key: 301727597
• Report Number: 1422375-2022-00044
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/03/2022,10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KCL-LED
• Device Catalogue Number: P1005600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2022
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other