MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, AIR-POWERED, DENTAL

Model Number PER-PTL-P

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Emphysema (1832); Swelling (2091); Chemical Exposure (2570); Patient Problem/Medical Problem (2688)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

This event occurred in europe, but similar products are marketed in the us under k112673.On december 14, 2016, nakanishi contacted the distributor to request patient information and the serial number.Nakanishi has not obtained any information as of this report.

Event Description

On (b)(6) 2016, nakanishi received information from a distributor ((b)(4)) describing a patient injury.Details are as follows.- the event occurred on (b)(6) 2016.- the patient developed symptoms of emphysema during treatment while the dentist was using an nsk perio mate handpiece.- as an initial response, nsk united kingdom provided msds to the dentist to explain that glycine powder is highly water-soluble, and it will not retain in the subgingival area.

Manufacturer Narrative

Nakanishi took the following actions to obtain further information about the event, the patient and the production serial 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 further information about the event, the patient and the serial 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 serial number, nakanishi could not take any investigation approach, including dhr examination.

• Brand Name: NSK
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 6193971
• MDR Text Key: 62971900
• Report Number: 9611253-2016-00075
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: PER-PTL-P
• Device Catalogue Number: Y1002654
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other