MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE LUX M8900 L; DENTAL HANDPIECE

Model Number M8900 L

Device Problem Dent in Material (2526)

Patient Problem Burn(s) (1757)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The visual and functional inspection prior to the repair showed that the product was damaged.Handpiece head is dented and interfering turbine rotation.Push button stuck in due to dented head and backcap which rubs on chuck release when turbine is in motion.This caused a higher friction and led to the overheating of the handpiece head.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare and how to check the handpiece for each treatment and how to use it.Caution in cases which - if not prevented - can lead to minor or moderate injury.2.3 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.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 is not seated firmly in the handpiece.Observe the following instructions in order to guarantee optimum functioning and prevent material damage: service the medical device with care products and systems regularly as described in the instructions for use.

Event Description

Handpiece head overheated during a standard treatment and caused a burn on patients lip.Up to now it was not possible to reach the customer therefore further data are not available yet.Date of event is best estimate.

Event Description

It was now possible to contact the dentists office to get further details about the incident: dentist was preparing to do a class 5, routine filling on tooth number 29.During the procedure the handpiece became very hot.Dentist stopped the procedure and noticed that the patient had a burn blister forming on the lower lip where the handpiece touched the patient.The patient was unaware that he was burned as he was numb.Dentist stopped using the handpiece and finished the procedure as planned with a different handpiece in the office.The doctor informed the patient what had happened and applied vaseline to the injury.The patient was very understanding and did not require medical care.

• Brand Name: MASTERTORQUE LUX M8900 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 11154838
• MDR Text Key: 256431346
• Report Number: 3003637274-2021-00002
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8900 L
• Device Catalogue Number: 1.008.7800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR