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

Model Number M8900 L

Device Problems Overheating of Device (1437); Failure To Service (1563)

Patient Problem Burn, Thermal (2530)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The visual and functional inspection prior to the repair showed that the chuck was worn out, the bearings have been vibrating and the heat up was reproducible during a short test run.The turbine did not reach the requested speed anymore.After disassembling of the product it got visible that the ball bearings have been worn out.This causes higher friction and hence heat up of the product.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.- the device should be cleaned, serviced and stored in a dry location, according to instructions, if it will not be used for a longer period.- 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.(b)(4).

Event Description

During a filling procedure to tooth# 3 & 4, the patient was burned at right corner of mouth.Burn diameter was 6 mm x 10 mm.Patient was prescribed triamcinolone acetonide ointment and told to do warm salt/water rinses.

• Brand Name: MASTERTORQUE LUX M8900 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• MDR Report Key: 7479721
• MDR Text Key: 107110902
• Report Number: 3003637274-2018-00018
• 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: Dentist
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: M8900 L
• Device Catalogue Number: 1.008.7800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Distributor Facility Aware Date: 04/06/2018
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 04/06/2018
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 05/02/2018
• 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 Outcome(s): Other
• Patient Age: 19 YR