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

Model Number M8700 L

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

The functional and visual check of the instrument prior to the repair showed that it was running out of specification.During the test run it was noticeable that bur was wobbling, and the bearings have been vibrating.This indicated already that the ball bearings have been worn out.During disassembling of the instrument, they fell apart due to wear and tear.To avoid such issues the instruction for use contains already following warnings, notesand advises: 2.2 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.2.5 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.Define the service interval depending on the frequency of use.

Event Description

During a crown preparation to tooth #2 the instrument caused a blood blister at patients' cheek.According to user the instrument was getting hot and ice cold.User applied some vaseline to the blister, no medical care necessary.

• Brand Name: MASTERTORQUE MINI LUX M8700 L
• Type of Device: DENTAL 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 Key: 12330396
• MDR Text Key: 266845813
• Report Number: 3003637274-2021-00030
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8700 L
• Device Catalogue Number: 3.001.0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1