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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH COMFORTDRIVE 200XDR DENTAL HANDPIECE

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KAVO DENTAL GMBH COMFORTDRIVE 200XDR DENTAL HANDPIECE Back to Search Results
Model Number 200XDR
Device Problems Overheating of Device (1437); Dent in Material (2526)
Patient Problem Burn, Thermal (2530)
Event Date 03/11/2015
Event Type  Injury  
Manufacturer Narrative
During the analysis of the product it was found that the head had a dent. This caused the back cap to stick in after inserting the bur. The result was unusual inner friction and hence the heat up of the head. The dent shows that the handpiece received a strong hit, e. G. A drop during reprocessing. The ifu contains several notes and warnings to avoid that handpieces which are running out of specification get used for treatments: 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 handpieces: the service instructions for handpieces must be precisely following when using kavo spray or quattrocare care systems. Before each use, the handpiece must be checked for external damage. Before each use, perform a test run with the handpiece, and watch for atypical heating and unusual noise and vibration. Immediately stop using handpieces that act unusual. Never press the push button 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. Exemption number e2010020. Kavo dental gmbh germany (the manufacturer) is submitting the report on behalf of kavo dental usa (the importer). [(b)(4)].
 
Event Description
During a standard dental treatment the handpiece heated up and caused a burn on the patients tongue with the size of a quarter. Doctor decided to perform a diode laser treatment to help healing. Patient was prescribed ao provantage antioxidant gel.
 
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Brand NameCOMFORTDRIVE 200XDR
Type of DeviceDENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, 88400
GM 88400
Manufacturer (Section G)
KAVO DENTAL GMBH
bismarckring 39
biberach / riss, 88400
GM 88400
Manufacturer Contact
klaus reisenauer
bismarckring 39
biberach / riss, bw 88400
GM   88400
MDR Report Key9680462
MDR Text Key178208289
Report Number3003637274-2015-00002
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 04/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number200XDR
Device Catalogue Number1.007.3570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2015
Distributor Facility Aware Date03/11/2015
Device Age4 YR
Event Location Other
Date Report to Manufacturer03/11/2015
Date Manufacturer Received03/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/07/2020 Patient Sequence Number: 1
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