MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERMATIC LUX M05 L; DENTAL ELECTRICAL HANDPIECE

Model Number M05 L

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

The analysis of the instrument showed that it had a dent in the head close to the push button.This caused the push button to stick in, rubbing on inner spinning parts and hence causing heat up.A dent is a sign that the instrument received a strong external hit, e.G.By dropping it.After disassembling it got visible that the ball bearings also have been worn, presumably due to increased wear caused by the damage.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.

Event Description

During a buccal preparation on tooth #30 the instrument heated up and caused a burn on inner cheek, approximately 3mm in size.There was no medical care necessary.

• Brand Name: MASTERMATIC LUX M05 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: 19190039
• MDR Text Key: 341120274
• Report Number: 3003637274-2024-00013
• 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: 04/26/2024

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: M05 L
• Device Catalogue Number: 1.009.3640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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