MAUDE Adverse Event Report:; NONE

Device Problems Inadequate Instructions for Healthcare Professional (1319); Mechanical Problem (1384)

Patient Problems Peeling (1999); Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Cause of overheating: cause of overheating in this case, we judge the damage of bearing which assembled top of hand piece.This bearing damage caused rotational resistance, then overheated abnormal.The factor of damage of bearing is lack of maintenance.This caused accumulation of dirt, foreign object and corrosion.Then this rotational resistance became damage of bearing.Conclusions: we checked returned hp, it seems to lack of maintenance.Also in maintenance, please repetition - lubrication - maintenance carry out until dirt stops coming out using our product, panaspray plus.Moreover, this hand piece is motor drive and very different quality from air turbine.In case of become worn or foreign object into hand piece side of bearing and went wrong, output (rotation) from motor side is very strong, it let hand piece rotate forcibly.Then it caused damage of bearing.It might be strong overheating.To confirm condition of equipment and early discovery of abnormality, please check noise, vibration and overheating before using.After you check nothing these abnormalities, please use this hand piece.

Manufacturer Narrative

On july 20, 2019, nakanishi was informed by the distributor (nam) that nam had taken the following actions as a part of the ifu recall activities.On december 13, 2018, nam sent the updated operation manuals that contain the detailed reprocessing method to the dental office to prevent the devices from overheating.On december 17, 2018, nam confirmed the receipt of the operation manuals by the dentist through usps certified receipt.

• Type of Device: NONE
• Manufacturer Contact: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 4076515
• MDR Text Key: 20124327
• Report Number: 9611253-2014-00001
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor,distributor
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 07/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1