MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE MINI LUX M4500 L; DENTAL HANDPIECE

Model Number M4500 L

Device Problems Device Maintenance Issue (1379); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the handpiece prior to the repair showed that it was running out of specification.It did not reach the requested rpm anymore due to stiff bearings and water was leaking into the body of the handpiece.During short test run the handpiece had abnormal sound and the heat up was reproducible.Root cause was that the ball bearings have been worn out.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: 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 to ensure proper function, the medical device must be set up according to the methods described in the kavo instructions for use, and the care products and methods 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 should take into account the frequency of use.Service may only be provided by repair shops that have undergone training by kavo and that use original kavo replacement parts.

Event Description

The dental office informed that the handpiece heated up during several treatments but did not cause any injury.The patients just complained about heat.Dentist is not able to recall patients to pull files, hence age and gender could not be supplied.Also the 'date of event' is not known, we got just the information several month's ago.

• Brand Name: MASTERTORQUE MINI LUX M4500 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, 88400 ; GM 88400
• MDR Report Key: 7548360
• MDR Text Key: 109619920
• Report Number: 3003637274-2018-00027
• 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: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: M4500 L
• Device Catalogue Number: 1.007.1700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2013
• 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