MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL

Model Number NANO95LS

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348); Burn, Thermal (2530); Patient Problem/Medical Problem (2688)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Nakanishi is now trying to obtain further information about the event including the patient.This event occurred in (b)(6), but similar products are marketed in the us under k972569.

Event Description

On april 6, 2018, nakanishi received an e-mail from a distributor (b)(4) about a handpiece overheating.Details are as follows.The event occurred on (b)(6) 2018.A dentist was performing a dental procedure using the nano95ls handpiece (serial (b)(4)).During the procedure, the handpiece overheated and burned a patient.

Manufacturer Narrative

Nakanishi took the following actions to obtain the patient information, however no information was provided.On april 25, 2018, nakanishi contacted the distributor (b)(4) via nsk (b)(4) for the information and received an e-mail from (b)(4) stating that (b)(4) forwarded the "additional information form" (information request form) to the dentist.On june 22, 2018, nakanishi sent an e-mail to (b)(4) to ask whether or not the dentist had provided the information.No response was received.Several days later (exact date unknown), nakanishi made a phone call to (b)(4) to hear the progress.No one was available in the office.After the event, the device was returned from the dentist to the distributor, repaired by the distributor and sent back to the dentist.Therefore, nakanishi could not evaluate the actual device and the dhr examination was the only investigation approach nakanishi took.As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.

• Brand Name: NSK
• Type of Device: HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, 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: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 7463628
• MDR Text Key: 106574368
• Report Number: 9611253-2018-00022
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: NANO95LS
• Device Catalogue Number: C1099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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