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

Model Number E680 LS

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

Patient Problem Burn, Thermal (2530)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

A visual inspection did not show any deviations like dents.The visual condition is good.During the following test run the overheating of the head was reproducible.After the disassembling of the product it got visible that the cage of the ball bearing was broken.This causes abnormal friction in the bearing and hence heat up.The production code on the turbine shows that the original parts have been assembled in the product.Hence it is normal wear if a ball bearing fails after >4 years of use.In addition, grooves got visible inside the push button which indicates that it was pressed while the product was in use.It is likely that it was in direct contact to the used mirror.This causes immediate heat up of the push button.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 dental treatment the instrument heated up and caused a burn to patient's cheek.According to dentist he used a mirror to retract the cheek to avoid the contact between the instrument and the cheek.The heat of the instrument must have been transmitted via the mirror to the cheek as the burn had the size of the mirror and its handle.Unfortunately, the lip of the patient got numb as a result of the burn therefore he has directly been sent to an oral surgeon for further investigation.Lip was 8 days after the incident still numb.

• Brand Name: 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, bw 88400 ; GM 88400
• MDR Report Key: 8821121
• MDR Text Key: 152022643
• Report Number: 3003637274-2019-00027
• 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
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/24/2019

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: 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: 07/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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 Age: 53 YR