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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 Overheating of Device (1437); Failure To Service (1563)
Patient Problem Burn, Thermal (2530)
Event Date 12/27/2017
Event Type  Injury  
Manufacturer Narrative
During the repair of the product an analysis has been carried out. During a short test run the heat up was reproducible. The power consumption was far out of specification which shows that the bearings are running stiff / gritty. After disassembling of the product it got visible that inside the handpiece has been a high debris level. Debris causes unusual friction within all moving parts which results in stronger wear and temperature increase. Root cause for high debris level is that the handpiece gets not reprocessed / maintained as requested by user instruction. 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. (b)(4).
 
Event Description
During a restoration procedure on tooth #3 and #29 the patient was burned on right side of cheek, tongue and corner of lip. The dentist feels that this must have happened when he removed the handpiece out of patient's mouth. The dentist prescribed magic swizzle and suggested an ora-gel topical. In the dental office was a triple antibiotic ointment applied.
 
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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
MDR Report Key7205296
MDR Text Key97724959
Report Number3003637274-2018-00001
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 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2018
Is this an Adverse Event Report? Yes
Device Operator Dentist
Device Model Number200XDR
Device Catalogue Number10073570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/19/2018
Distributor Facility Aware Date12/28/2017
Device Age3 YR
Event Location Other
Date Report to Manufacturer12/28/2017
Date Manufacturer Received12/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2014
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: 01/19/2018 Patient Sequence Number: 1
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