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

Model Number S20

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/25/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 , nakanishi received an email from a distributor (nsk europe) about a patient's accidental ingestion of an nsk scaler tip.The details are as follows: the event occurred on (b)(6) 2022.The dentist was performing a periodontal debridement of a patient using the s20 scaler tip (lot no: 214) with an nsk handpiece, s970kl serial no: (b)(4) setting a power level 2.During the procedure, the scaler tip suddenly fractured in the patient's mouth, and the patient swallowed the tip.Despite an x-ray check was performed, the broken part could not be found, therefore it was immediately sucked by the vacuum canula when it broke, or already eliminated by natural means.

Manufacturer Narrative

According to the distributor, the dentist refused to provide any information about the patient other than the patient's age and sex.Upon receiving the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [report no: (b)(4)].These activities are described in more detail below.Methodology used: a) nakanishi examined the device history record and the repair history for the subject s20 scaler tip [lot no: 214].There were no problems observed during manufacturing or testing noted in the dhr.There were no repair history records since the device is a consumable.B) nakanishi conducted a visual inspection of the returned device.Nakanishi observed breakage around the water irrigation hole on the tip.Nakanishi also observed brittle fracture appearance on most of the broken surface of the tip.C) nakanishi took photographs of the tip and kept them in the investigation report no: (b)(4).Conclusions reached based on the investigation and analysis results: a) nakanishi identified from the findings in the visual inspection that the cause of the breakage of the returned scaler tip was stress on the device.Nakanishi considers the possibility from similar event that nakanishi has experienced in the past that the combined influences by a heavy load and a strong impact such as dropping on the device could result in the reported scaler tip breakage.B) misuse by the user led to the above issue, which contributed to the reported event.C) in order to prevent a recurrence of the breakage of the device, nakanishi took the following actions: c.1) nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions.C.2) nakanishi will report the above evaluation results to the distributor and directed the distributor to remind the user of the importance of using the device as instructed in the operation manual.

• 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: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 16179821
• MDR Text Key: 307498196
• Report Number: 9611253-2023-00005
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K991021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2023

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: S20
• Device Catalogue Number: Z252441
• Device Lot Number: 214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2022
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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: 64 YR
• Patient Sex: Female