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Model Number 200XDR
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
An analysis of the product was not possible as the dentist did not send in the product. During conversation by email and phone it was stated that the product was repaired at local repair shops which are unknown to kavo. Therefore, it is not known if the product was repaired with original spare parts or if third party parts have been used. In addition it was stated that the handpiece was used to retract the lip from the treatment area which is a use against the ifu. To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: 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. Caution: hazard from the use of handpieces equipped with electronic micromotors. Electronic micromotors generate much more energy than conventional pneumatic turbines and motors. Given the higher torque and speed, handpieces that are poorly serviced, damaged or used improperly can overheat which can cause serious burn injuries to the patient. Observe the following points. 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! we recommend returning the handpieces to kavo at regular intervals for testing, setup and servicing. The frequency of the care depends on the instruments use. The contra-angle handpieces must be setup according to the kavo instructions to ensure proper functioning. The following individuals are authorized to repair and service kavo products: technicians at kavo branches throughout the world. Technicians specially trained by kavo. 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. Service may only be carried out by kavo-trained repair shops using original kavo replacement parts. (b)(4).
Event Description
(b)(6) informed by email that during a patient procedure on (b)(6) 2018 the patient was burned on right corner of lip. He stated the patient had a full recovery and felt no pain after 24 hours. No ointment or medication given to patient for burn.
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Manufacturer (Section D)
bismarckring 39
biberach / riss, bw 88400
GM 88400
Manufacturer (Section G)
bismarckring 39
biberach / riss, bw 88400
GM 88400
Manufacturer Contact
klaus reisenauer
bismarckring 39
biberach / riss, bw 88400
GM   88400
MDR Report Key7702170
MDR Text Key114415800
Report Number3003637274-2018-00032
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Dentist
Type of Report Initial
Report Date 07/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number200XDR
Device Catalogue Number10073570
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse