MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, AIR-POWERED, DENTAL

Model Number KCL-LED

Device Problem Unintended Electrical Shock (4018)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, (b)(4), under report number 1422375-2022-00045.This device is similar product as k203791.Despite the following actions the distributor ((b)(4)) took for information about the adverse event, any injury, or the patients, the dental office did not provide the information.On september 20, 2022, (b)(4) made a phone call to the dental office, but the dentist or the assistant involved in the event was not available at that moment and left a message with (b)(4) contact information.There was no response from the dental office.On the same day, (b)(4) sent an email to the dental office, but no response was returned.On september 26, 2022, (b)(4) made a phone call, but the dentist or the assistant was not available and asked the front desk staff to call (b)(4).(b)(4) has received no phone call from the dental office.

Event Description

On (b)(6) 2022, nakanishi became aware of a malfunction of nsk couplers through a complaint input into the complaint database by a distributor ((b)(4)).According to the distributor ((b)(4)), they received a report from one of their distributors in canada that their customer had reported that patients were being shocked by two of their handpiece couplers on (b)(6) 2022.This mdr is regarding the coupler with the serial number (b)(4).

• Brand Name: NSK
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 15602896
• MDR Text Key: 301730112
• Report Number: 9611253-2022-00074
• 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: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/14/2022

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: KCL-LED
• Device Catalogue Number: P1005600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other