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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERMATIC LUX M25 L; DENTAL ELECTRICAL HANDPIECE

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KAVO DENTAL GMBH MASTERMATIC LUX M25 L; DENTAL ELECTRICAL HANDPIECE Back to Search Results
Model Number M25 L
Device Problems Overheating of Device (1437); Dent in Material (2526); Physical Resistance/Sticking (4012)
Patient Problem Burn(s) (1757)
Event Date 10/11/2023
Event Type  malfunction  
Event Description
During a treatment to restore tooth 19 and 20, the instrument became too hot and caused a superficial burn on the left side of the tongue, extending to the apex of tongue.The burned area had a white appearance and had the size of the back cap.Patient was called on same evening of incident and was in moderate pain after numbness went away.No medical care necessary.
 
Manufacturer Narrative
The handpiece has been checked visually and functionally against the valid specification.It was running slow and the heat up was reproducible.It was found that the head had a dent at the push button.A dent is the result of a strong external force, e.G.A drop of the handpiece.Even if this impact does not obviously cause a malfunction it could cause a misalignment of the inner spinning parts which causes higher friction and hence stronger wear.After disassembly of the instrument it was found that the ball bearings have been worn out, also black residue could be found in the handpiece which is a sign that the reprocessing between the treatments is not done according the ifu.At the inner push button was a circular mark visible from rubbing on chuck release while handpiece is running.Root cause is either that during treatment the handpiece is used to retract soft tissue (tongue) or the button stuck in due to the dent.To avoid such issues the ifu 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 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.
 
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Brand Name
MASTERMATIC LUX M25 L
Type of Device
DENTAL ELECTRICAL 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, 88400
GM   88400
MDR Report Key18148660
MDR Text Key328283290
Report Number3003637274-2023-00025
Device Sequence Number1
Product Code EGS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM25 L
Device Catalogue Number1.009.3630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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