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

Model Number M05 L

Device Problems Overheating of Device (1437); Dent in Material (2526); Device Handling Problem (3265); Physical Resistance/Sticking (4012)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

The handpiece has been checked visually and functionally against the valid specification.It was found that the running characteristics have been out of specification with a too high power consumption and bearings which have been grinding and vibrating.The body shell showed a dent which indicates that it received a strong external hit e.G., by dropping down.The heat up was reproducible during the test run.After disassembly of the product heavy residue got visible inside the instrument.This shows that the reprocessing was not carried out as specified.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: 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.Caution: burning hazard from hot instrument head or hot instruments cover.If the instrument overheats, burns may arise in the oral area.Never contact soft tissue with the instrument head or instrument cover the following guidelines must be observed to ensure save use of the electrically driven contra-angle handpieces: the service instructions for contra-angle handpieces must be precisely following when using kavo spray or quattrocare care systems.Before each use, the contra-angle handpiece must be checked for external damage.Before each use, perform a test run with the contra-angle handpiece, and watch for atypical heating and unusual noise and vibration.Immediately stop using contra-angle handpieces that act unusual.Never press the push button during operation.This also includes lifting the cheek or tongue.To ensure proper function, the medical device must be set up according to the reprocessing methods described in the kavo instructions for use, and the care products and care systems described therein must be used.Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.This service interval depends on the frequency of use and should be adjusted accordingly.

Event Description

Dental office informed that during a dental procedure at tooth #12 and 13 the handpiece heated up and burned patient at the lip.The burn was very minor, it was barely grazed and noticeable.Patient was not worried about burn as it was very minor.Hence there was no medical care or follow up 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: 13857533
• MDR Text Key: 290291153
• Report Number: 3003637274-2022-00011
• 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: 03/22/2022

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: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2022
• Initial Date FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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