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

Model Number S1

Device Problems Break (1069); Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, an nsk air scaler tip, s1 (lot no.0f6) was returned from a distributor to nakanishi for repair.There was a note coming with the tip referring to the tip breakage.Upon receipt of the information, nakanishi made a phone call to the dentist to obtain the additional information.Details are as follows.On (b)(6), the dentist was providing dental scaling to a patient.The patient was not anesthetized.The tip was suddenly broken as if slipping.The dentist did not put an excessive force on the tip.

Manufacturer Narrative

On (b)(6) 2016, nakanishi was aware of the information from the dentist that the patient involved in the event had not suffered health hazards from the tip breakage.Upon receipt from a distributor of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [(b)(4)].These activities are described in more detail below.Methodology used : nakanishi conducted a visual inspection of the returned device.Nakanishi observed breakage around the water irrigation hole of the tip.Nakanishi also confirmed fatigue/ductile fracture on the broken surface of the tip.Nakanishi took photographs of all the damages on the tip and kept them in a file.Conclusions reached based on the investigation and analysis results : nakanishi could not identify the cause of tip being broken because the above visual inspection is the only evaluation nakanishi can make with the returned device, therefore, nakanishi were not able to reproduce the situation at the time of the event.In order to prevent a recurrence of the tip breakage, nakanishi took the following actions.Nakanishi reviewed the operation manual for ti-max s970, a handpiece which is used along with the s1 tip that contains instructions for use for s1 tip.As a result, nakanishi reconfirmed clarity and understandability of the instructions.Nakanishi reported the above evaluation results to the dentist and reminded the dentist of the risk of the tip used under the overload.

• 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: ken block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809544
• MDR Report Key: 5294219
• MDR Text Key: 33428510
• Report Number: 9611253-2015-00122
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

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: Dentist
• Device Model Number: S1
• Device Catalogue Number: Z252411
• Device Lot Number: 0F6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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
• Patient Age: 45 YR
• Patient Weight: 70