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U.S. Department of Health and Human Services

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

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KAVO DENTAL GMBH COMFORTDRIVE 200 XD DENTAL ELECTRICAL HANDPIECE Back to Search Results
Model Number 200 XD
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
During the repair of the product an analysis has been carried out. The visual inspection of the product did not show any deviations. During the functional test it was directly noticeable that the inserted bur was hard to turn and it was turning gritty. During the following test run the heat up was even without load reproducible. The power consumption was far out of the specification. After disassembling of the product, a lot of black residue got visible and the ball bearings have been dry instead of oily. This lead to the assumption that the maintenance was not performed as required by 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 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. Issue reported as similar product (comfortdrive 200xdr) gets distributed in the usa.
 
Event Description
During a dental treatment the head of the handpiece got very hot and caused a blister on inner side of patients lip. Patient is female in her fourties. No medical care regarding the burn necessary. Date of incident was not supplied hence best estimate has been entered.
 
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Brand NameCOMFORTDRIVE 200 XD
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
MDR Report Key8146237
MDR Text Key130312894
Report Number3003637274-2018-00052
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUK
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 12/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number200 XD
Device Catalogue Number1.000.5500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2015
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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