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

Model Number	P10
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On may 14, 2025, nakanishi received an email from a distributor (b)(4) about a patient's accidental ingestion of an nsk scaler tip.The details are as follows: - the event occurred on (b)(6) 2025.- the dentist was performing a prophylaxis cleaning on a patient using the p10 scaler tip (lot no.Unknown) with an ultrasonic built into chair (a-dec), acteon (satelec brand) speed 5 (mid speed setting).- during the procedure, the scaler tip fractured at the shank, and the patient swallowed the tip.- the patient went to the hospital emergency room at 8pm on (b)(6) 2025 and was discharged at 10pm.- x-rays confirmed the tip traveled to the stomach.The tip was passed via bowel movement on (b)(6) 2025.- no further follow up was reported.
Additional Manufacturer Narrative
Nakanishi is still trying to obtain information about the event, including information about the device.
Additional Manufacturer Narrative
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 p10 scaler tip [lot no.225].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 and ductile fracture on a part 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
• Common Device Name: 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: 22173731
• Report Number: 9611253-2025-00027
• Device Sequence Number: 9401639
• Product Code: ELC
• UDI-Device Identifier: 04560264563254
• UDI-Public: (01)04560264563254(10)225
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K113530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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
• Operator of Device: Health Professional
• Device Model Number: P10
• Device Catalogue Number: 5010241U0
• Device Lot Number: 225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White