MAUDE Adverse Event Report: NAKANISHI, INC. NSP P10; SCALER ULTRASONIC

Model Number P10 PERIO TIP

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

The following information is from (b)(6) regarding a device manufactured by (b)(4) event summary: hygienist was working with the patient and the patient complained of having metal taste in mouth, within few minutes tip broke off at the shaft.Hygienist told patient to not swallow, a hygienist tried to suction, did not see.Wasn't sure if she ingested or not, patient just had gastro surgery, they sent patient to hospital for chest x-ray.Follow up: x-rays did not show any metal pieces.Customer thinks the metal piece was suctioned up by the suction pump.Nakanishi has requested additional information from (b)(4) regarding this event via written letter (b)(6) 2015.(b)(4) did not return handpiece to nsk for the manufacturer's evaluation.

Manufacturer Narrative

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

• Brand Name: NSP P10
• Type of Device: SCALER ULTRASONIC
• Manufacturer (Section D): NAKANISHI, INC.; 700 shimohinata; kanuma-shi, tochigi-ken ; JA
• Manufacturer Contact: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 4512632
• MDR Text Key: 5409114
• Report Number: 9611253-2015-00012
• 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: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 01/14/2015,11/23/2017

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: Other
• Device Model Number: P10 PERIO TIP
• Device Catalogue Number: ZS17410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 38 MO
• Event Location: Other
• Date Report to Manufacturer: 01/21/2015
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 02/09/2015
• Supplement Dates Manufacturer Received: 10/14/2016
• Supplement Dates FDA Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR