MAUDE Adverse Event Report: NAKANISHI INC. NSK; SCALER, ULTRASONIC

Model Number SG5

Device Problems Break (1069); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, nakanishi sent an email to obtain further information about the event including the patient information, but no response has been returned.

Event Description

On (b)(6) 2017, nakanishi was made aware of breakage of an nsk tip from a conversation with a dentist.The details are as follows.The event occurred on (b)(6) 2017.While the dentist was performing a dental procedure using the tip, sg5 (lot no.Unknown), the tip suddenly fractured.The dentist disposed of the broken tip.

Manufacturer Narrative

In addition to (b)(6) 2017, (b)(4) made phone calls to the hospital to ask the dentist to provide us with further information about the event and patient, and with the subject device for investigation on (b)(6) 2017 and (b)(6) 2018.However, (b)(4) received neither the information nor the device.

• Brand Name: NSK
• Type of Device: SCALER, ULTRASONIC
• 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: 7016798
• MDR Text Key: 93098955
• Report Number: 9611253-2017-00062
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: SG5
• Device Catalogue Number: Z305106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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