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U.S. Department of Health and Human Services

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

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KAVO DENTAL GMBH COMFORTDRIVE 200XDR DENTAL ELECTRICAL HANDPIECE Back to Search Results
Model Number 200XDR
Device Problems Device Maintenance Issue (1379); Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 07/11/2017
Event Type  malfunction  
Manufacturer Narrative
During a test run of the product the heat up was reproducible and it showed that the handpiece was running out of specification. After disassembling of the product it was found that the ball bearings have been worn out and gritty. This causes higher friction and hence increase of temperature. In addition there have been groove marks visible at the inner side of the push button. This indicates that it has been pressed while the tool was spinning. This again causes higher friction and hence increase of temperature. 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: 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 push button 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
During a dental endo and crown prep of tooth# 26 and 30, patient was burned on right corner of lip. Burned diameter was size of handpiece head. Office applied over the counter oxyfresh gel to lip. No medical care necessary. As dental office was not able to identify which product caused the burn a second handpiece was sent in for analysis. As both handpieces are in the same condition it is not possible to assign the incident to one of both. Therefore a second mdr is issued for the same burn but with the second handpiece. See also mdr #3003637274-2017-00047.
 
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Brand NameCOMFORTDRIVE 200XDR
Type of DeviceDENTAL ELECTRICAL 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
735156
MDR Report Key6783878
MDR Text Key82331782
Report Number3003637274-2017-00046
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,user faci
Reporter Occupation Dentist
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number200XDR
Device Catalogue Number1.007.3570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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