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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE MINI LUX M8700 L DENTAL HANDPIECE

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KAVO DENTAL GMBH MASTERTORQUE MINI LUX M8700 L DENTAL HANDPIECE Back to Search Results
Model Number M8700 L
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
Unfortunately, the adverse event was only reported after the repair had already been carried out. Therefore a detailed analysis was not possible anymore retrospectively. But the documented findings of the incoming inspection show that the speed and the retention force have been too low. This indicates that the ball bearings, and the chuck have been worn out. To avoid such issues, the instruction for use contains already following warnings and notes: technical condition: a damaged device or components 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. Safety checks may only be performed by trained service personnel. 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. Service and repair: following expiry of the warranty, check the cutter/grinder holding system and quick stop 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. Defined the service interval depending on the frequency of use. Inserting the milling tools or diamond grinders. Note: only use carbide cutters or diamond grinders that comply with en iso 1797-1 type 3, are made of steel or hard metal and meet the following criteria: shaft diameter: 1. 59 to 1. 60 mm; overall length: max. 21 mm; shaft clamping length: at least 9 mm; blade diameter: max. 2 mm. Caution: hazard from defective chuck system. The cutter or grinder could fall out and cause injury. Pull on the dental burr or rips abrasives to check if the clamping system is functioning properly and that the tool is firmly clamped. Wear gloves, or a thimble to check, insert, or remove the bits to prevent injury and infection.
 
Event Description
The dentist was performing a dental procedure using a kavo master torque mini lux m8700 l dental handpiece when allegedly the dental bur separated from the handpiece and was swallowed by the patient. The patient was taken to the hospital and x-rays were taken which showed the object was ready to pass, and no further treatment was required. Follow up was made by the dental facility office manager on (b)(6) 2020 with the mother of the patient, she stated that the patient had passed the bur. There were no injuries reported.
 
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Brand NameMASTERTORQUE MINI LUX M8700 L
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 Key10905116
MDR Text Key219570280
Report Number3003637274-2020-00023
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM8700 L
Device Catalogue Number3.001.0000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2015
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: 11/25/2020 Patient Sequence Number: 1
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