MAUDE Adverse Event Report: NAKANISHI, INC. (NSK) NSK P1; TIP, SCALAR, ULTRASONIC

Model Number P1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 nsk america received a telephonic complaint from (b)(6).The dentist wanted to lodge a formal complaint regarding an ultrasonic scalar tip that had broke upon first use while in the pt's mouth.The dentist was concerned as the pt had nearly aspirated the tip.The tip was recovered due to the quick reaction of the dentist and his assistant to prevent the tip from being aspirated or swallowed.A replacement tip was provided at no charge and federal express ground call tag was issued to retrieve the damaged tip.Tip was received on (b)(6) 2014 and inspected on (b)(6) 2015 by (b)(4) qa mgr.Tip was found to be broken but (b)(4) does not have the equipment available to determine the specific cause of failure.Tip was shipped to nakanishi on (b)(6) 2014.And received on august 18, 2014.Investigation in process.

Manufacturer Narrative

Upon receipt of the tip nakanishi conducted a failure analysis of the returned devices that included breakage of tip.These activities are described in more detail below.Methodology: nakanishi reviewed the device history record for the subject p1 tip (lot no.Odx).There were no problems observed during the manufacture or testing of the lot noted in the dhr; nakanishi conducted a visual inspection of the returned tip, identifying that the returned tip was broken at a point half way from the end; nakanishi conducted testing to replicate the event.Several tips were run in a handpiece at varying power ranges, uncovering that running the tip at a power range higher than that recommend by nakanishi causes the tip to break.Conclusion: nakanishi has concluded that breakage of this type was caused by a handling /misuse error by the operator of the device.

Manufacturer Narrative

On (b)(4) 2016, nakanishi heard from the distributor that no additional information regarding patient was available.

• Brand Name: NSK P1
• Type of Device: TIP, SCALAR, ULTRASONIC
• Manufacturer (Section D): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI, INC. (NSK); 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: ken block ; 1201 richardson dr suite 280; richardson, TX 75080 ; 9724809554
• MDR Report Key: 4307870
• MDR Text Key: 20120621
• Report Number: 9611253-2014-00008
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2014,06/16/2017

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: Other
• Device Model Number: P1
• Device Catalogue Number: Z217404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2014
• Event Location: Other
• Date Report to Manufacturer: 08/08/2014
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 11/28/2014
• Supplement Dates Manufacturer Received: 10/14/2016; 10/14/2016
• Supplement Dates FDA Received: 02/24/2015; 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other