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

Model Number M4500 L

Device Problems Overheating of Device (1437); Dent in Material (2526)

Patient Problems Burn, Thermal (2530); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

A brief visual and functional check prior to the repair showed that the head of the instrument had a dent.This dent caused the push button to stick in causing high friction and hence heat up.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.Damage, irregular noise during operation, excessive vibration, unusual build-up of heat or if the cutter or grinder cannot be firmly held.Stop work and seek service support.Caution: burning hazard from hot instrument head and instruments cover.If the instrument overheats, burns may arise in the oral area.Never contact soft tissue with the instrument head.(b)(4).

Event Description

The instrument was sent in for repair with the statement 'burned patient'.Up to now it was not possible to get further details.

Manufacturer Narrative

When it was finally possible to reach the dental office, it was stated that the original comment, that the handpiece caused a burn during a treatment, was a mistake.Their documentation does not indicate any adverse event associated with this handpiece.

Event Description

No adverse event.

• Brand Name: MASTERTORQUE MINI LUX M4500 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 10453240
• MDR Text Key: 204383741
• Report Number: 3003637274-2020-00015
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: 130560
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4500 L
• Device Catalogue Number: 1.007.1700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1