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

Model Number G5

Device Problems Break (1069); Fracture (1260); Device Or Device Fragments Location Unknown (2590); Material Integrity Problem (2978)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

As of (b)(6) 2016, nakanishi is still contacting the distributor for more information, including patient information and product lot number.

Event Description

On (b)(6) 2016, nakanishi received an e-mail from a distributor (nsk (b)(6)) about a fracture of an nsk scaler tip.Details are as follows.The event occurred on (b)(6) 2016.While a dentist was providing a patient with a dental scaling, the nsk g5 scaler tip suddenly fractured in the patient's mouth.The dentist tried to find the fractured portion but could not locate the fractured tip.The patient was sent to a hospital for a chest x-ray.There was no fractured tip observed in the x-ray image.

Manufacturer Narrative

Nakanishi took the following actions to obtain information about the patient and the production lot number, and whether or not the device involved in the event would be returned for investigation.However, nakanishi could not receive any of the information.On june 26, 2017, nakanishi sent an email to nuk for the information.Nuk returned an email stating that: 1) there was no information about the patient and the lot number.2) the subject device had not been/would never be returned from the user.On november 16, 2017, nakanishi sent an email to nuk for the information.There was no information available.On january 18, 2018, nakanishi had a conversation with the nuk manager during his visit to nakanishi.Nuk did not have the information.Since nakanishi did not receive the subject device and the lot number, nakanishi could not take any investigation approach, including dhr examination.

• 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
• MDR Report Key: 6192717
• MDR Text Key: 62919450
• Report Number: 9611253-2016-00072
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• PMA/PMN Number: K113530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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?: No
• Device Operator: Dentist
• Device Model Number: G5
• Device Catalogue Number: Z217105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other