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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH KAVO EXPERTTORQUE LUX E680 LS DENTAL HANDPIECE

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KAVO DENTAL GMBH KAVO EXPERTTORQUE LUX E680 LS DENTAL HANDPIECE Back to Search Results
Model Number E680 LS
Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Dent in Material (2526)
Patient Problem Burn(s) (1757)
Event Date 02/25/2021
Event Type  malfunction  
Manufacturer Narrative
A short visual inspection and a test run prior to the repair showed that the heat up was reproducible. Root cause was that the head of the handpiece had several dents. One of these was at the back cap which caused the push button to stick in. As a result it was rubbing on the inner moving part, causing friction and hence heat up. To avoid such issues the instruction for use contains several warnings and notes: 2. 2 technical condition: a damaged device or component could injure patients, users and third parties. Only operate devices or components if they are undamaged on the outside. Check that the device is working properly and is in satisfactory condition before each use. Have parts with sites of breakage or surface changes checked by the service. If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions. Damage. Irregular running noise. Excessive vibration. Overheating. Dental bur or diamond grinder is not firmly locked in the handpiece. The improper use of the device could lead to burns or injuries. Never touch soft tissue with the handpiece head or instrument cover. 2. 5 service and repair: following expiry of the warranty have the tool holding system checked once a year. Kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check. Define the service interval depending on the frequency of use. Incident is reported as similar products get distributed in the usa.
 
Event Description
During a standard dental treatment the handpiece heated up and burned the patient on lip which blistered. No medical care necessary.
 
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Brand NameKAVO EXPERTTORQUE LUX E680 LS
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, 88400
GM   88400
MDR Report Key11594676
MDR Text Key243140515
Report Number3003637274-2021-00008
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE680 LS
Device Catalogue Number1.006.4600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2020
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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