MAUDE Adverse Event Report: KAVO DENTAL GMBH KAVO EXPERTTORQUE LUX E680 LS; DENTAL HANDPIECE

Model Number E680 LS

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Dent in Material (2526)

Patient Problem Burn(s) (1757)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

A short visual inspection and a test run prior to the repair showed that the heat up was reproducible.Root cause was that the head of the handpiece had several dents.One of these was at the back cap which caused the push button to stick in.As a result it was rubbing on the inner moving part, causing friction and hence heat up.To avoid such issues the instruction for use contains several warnings and notes: 2.2 technical condition: a damaged device or component 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.Have parts with sites of breakage or surface changes checked by the service.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions.Damage.Irregular running noise.Excessive vibration.Overheating.Dental bur or diamond grinder is not firmly locked in the handpiece.The improper use of the device could lead to burns or injuries.Never touch soft tissue with the handpiece head or instrument cover.2.5 service and repair: following expiry of the warranty have the tool holding system checked once a year.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.Incident is reported as similar products get distributed in the usa.

Event Description

During a standard dental treatment the handpiece heated up and burned the patient on lip which blistered.No medical care necessary.

• Brand Name: KAVO EXPERTTORQUE LUX E680 LS
• 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: 11594676
• MDR Text Key: 243140515
• Report Number: 3003637274-2021-00008
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/31/2021

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: E680 LS
• Device Catalogue Number: 1.006.4600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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: 27 YR