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

Model Number M8900 L

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Burn(s) (1757)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The visual and functional inspection prior to the repair showed that the product was running out of specification.The retention force of the chuck was too low, the product no longer reached the specified speed as the ball bearings have been running gritty and rough.Both is the result of a normal wear process.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: warning: hazards for the care provider and the patient.In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held.Do not use further and notify service.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.If there are any sites of breakage or clearly recognised changes on the surface, the parts must be 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 noise excessive vibration untypical heating no firm seating of the grinder or cutter in the instrument 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.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 standard dental treatment to teeth #3 & #4 the head of the instrument heated up and caused a round burn on the patients inner right cheek with 4mm in diameter.No medical care was necessary.

• Brand Name: MASTERTORQUE LUX M8900 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: 10904732
• MDR Text Key: 220573848
• Report Number: 3003637274-2020-00020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 10/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• 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 Age: 53 YR