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

Model Number M25 L

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

During an extraction treatment on teeth #19 and #21 the handpiece got hot and caused a burn on lower left lip, approximately 5mm in diameter.There was no medical care necessary for the burn.During the follow up regarding the dental work the burn was also checked and it was healing well.

Manufacturer Narrative

The handpiece has been checked visually and functionally against the valid specification.During the test run it was already found that the ball bearings have been running gritty and rough and the heat up was reproducible.This is already an indication that the ball bearings are worn out, which could be confirmed after disassembly of the instrument.Root cause for the heat up was that the handpiece has been used with worn out bearings which caused higher friction and hence heat up.In addition, it was found that not certified third-party spare parts have been installed.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: 2.2 improper use because the operation with an electric motor involves a higher torque, patients, users and other people can suffer injuries and serious burns if an instrument is damaged or used improperly.> check the technical condition before each use.> never press the push-button during operation of the device.> never use the instrument to keep the cheek, tongue or lip at a distance.> never touch soft tissue with the handpiece head or instrument cover.2.3 technical condition a damaged product or not kavo original components could injure patients, users or third parties.> only operate devices or components if they show no signs of damage on the outside.> check to make sure 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 personnel.> if the following defects occur, stop working and have the service personnel carry out repair work: · malfunctions · damage (e.G., from dropping) · irregular running noise · excessive vibration · overheating · dental bur is not seated firmly in the handpiece to ensure optimum function and to prevent property damage, please comply with the following instructions: > service the medical device regularly with care products and systems as described in the instructions for use.> the device should be reprocessed and stored in a dry location, according to instructions, if it is not to be used for an extended period of time.2.4 accessories and combination with other equipment use of non-authorised accessories or non-authorised modifications of the device could lead to injury.> only use accessories that have been approved for combination with the product by the manufacturer.> only use accessories that are equipped with standardised interfaces.> do not make any modifications to the device unless these have been approved by the manufacturer of the product.> use original kavo spare parts only.

• 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 Key: 19179127
• MDR Text Key: 341614055
• Report Number: 3003637274-2024-00012
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/25/2024

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: M25 L
• Device Catalogue Number: 1.009.3630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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
• Patient Outcome(s): Other