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

Model Number TI-MAX A600L

Device Problem Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

As of may 3, 2016, nakanishi has not received any information/details about the patient and event other than the event date.Nakanishi will continue to investigate the details on the patient and event.

Event Description

On (b)(6) 2016, an nsk handpiece, ti-max a600l (serial no.(b)(4)) was returned from a distributor to nakanishi for repair.There was a note coming with the handpiece stating that a dentist had cut patient's gum with the handpiece headcap.The only information nakanishi obtained about the event is as follows.The event occurred on (b)(6) 2016.

Manufacturer Narrative

Upon receiving the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [c160411-04-1].These activities are described in more detail below.Methodology used : a) nakanishi examined the device history record and the repair history for the subject ti-max a600l device [serial number (b)(4)].There were no problems observed during the manufacturing or testing noted in the dhr.There were also no repair history records since the device was shipped.B) nakanishi conducted a visual inspection of the returned device and found multiple dents on the outside of the handpiece that may have formed during long-term use.C) nakanishi then performed a visual inspection of the device with a mesoscope.Nakanishi confirmed damage on the engaging part between the head and the headcap.More precisely, nakanishi observed a dent on the head and on a part of the headcap sticking out.D) nakanishi took photographs of all of the damages confirmed in the above visual inspection and kept them in a file.Conclusions reached based on the investigation and analysis results: nakanishi identified that the cause of the patient's injury was the damaged head portion of the returned device.The damage was caused by high impact accidentally applied to the head during the long-term use, which contributed to the patient's injury.In order to prevent a recurrence of the patient's injury, nakanishi took the following actions: nakanishi reported the above evaluation results and explained the cause of the event to the dentist.Nakanishi replaced the damaged head and headcap with the new head and headcap and returned the fixed device to the dentist.

Manufacturer Narrative

During the second week of may 2016 (exact date unknown), nakanishi made a phone call to the dentist for patient information, but nakanishi could not obtain any information about the patient.

• 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
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: kenneth block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809554
• MDR Report Key: 5627009
• MDR Text Key: 44290621
• Report Number: 9611253-2016-00020
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

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?: No
• Device Operator: Dentist
• Device Model Number: TI-MAX A600L
• Device Catalogue Number: P666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2016; 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2006
• 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