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 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

When customer called to inform about the event they wanted to send the product in for analysis and repair.Unfortunately we did not receive the product up to now, therefore a root cause analysis was not possible, yet.

Event Description

During an occlusal adjustment on tooth #30 the hanpiece heated up and caused a burn to mucosa on the right cheek, opposite to tooth #30.Medical care was not necessary.

Manufacturer Narrative

The visual and functional inspection prior to the repair showed that the product was damaged.Handpiece head was 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 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, and 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.

• 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
• MDR Report Key: 11320275
• MDR Text Key: 231743724
• Report Number: 3003637274-2021-00006
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 03/04/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR