• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH EXPERTTORQUE LUX E679 L DENTAL HANDPIECE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KAVO DENTAL GMBH EXPERTTORQUE LUX E679 L DENTAL HANDPIECE Back to Search Results
Model Number E679 L
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
During a test run the heat up was not reproducible. But the product did not reach the requested minimum rpm which shows that the spinning parts are not running smoothly. Also the spray water was not good. After disassembly of the product it was found that the ball bearings have been stiff and the push button had a groove worn into it on the inner side. This shows that it has been depressed while the instrument was in use and is usually a sign that it has been used to lift soft tissue away from the treatment area. This causes unusual friction and hence heat up of the product. Also the worn ball bearing cause increase of temperature due to higher friction. To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: warning: hazards for the care provider and the patient. In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held. -> do not use further and notify service. Caution: burning hazard from hot instrument head or hot instruments cover. If the instrument overheats, burns may arise in the oral area. ->never contact soft tissue with the instrument head or instrument cover the following guidelines must be observed to ensure save use of the electrically driven contra-angle handpieces: >the service instructions for contra-angle handpieces must be precisely following when using kavo spray or quattrocare care systems. > before each use, the contra-angle handpiece must be checked for external damage. > before each use, perform a test run with the contra-angle handpiece, and watch for atypical heating and unusual noise and vibration. > immediately stop using contra-angle handpieces that act unusual. > never press the pushbutton during operation. This also includes lifting the cheek or tongue! to ensure proper function, the medical device must be set up according to the reprocessing methods described in the kavo instructions for use, and the care products and care systems described therein must be used. Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device. This service interval depends on the frequency of use and should be adjusted accordingly.
 
Event Description
The dental assistant informed during a phone call that on (b)(6) 2017 while performing crown prep to tooth# 3, the patient felt the handpiece heat up that felt uncomfortable on lower lip. No mark shown on lip. No ointment or medication given to patient for feeling heat from handpiece.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXPERTTORQUE LUX E679 L
Type of DeviceDENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, bw 88400
GM 88400
Manufacturer (Section G)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, bw 88400
GM 88400
Manufacturer Contact
klaus reisenauer
bismarckring 39
biberach / riss, bw 88400
GM   88400
MDR Report Key7128839
MDR Text Key95347000
Report Number3003637274-2017-00074
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dental Assistant
Type of Report Initial
Report Date 12/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model NumberE679 L
Device Catalogue Number1.006.9200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-