MAUDE Adverse Event Report: KAVO DENTAL GMBH EXPERTTORQUE LUX E679 L; DENTAL HANDPIECE

Model Number E679 L

Device Problem Overheating of Device (1437)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

During a test run the heat up was not reproducible.But the product did not reach the requested minimum rpm which shows that the spinning parts are not running smoothly.Also the spray water was not good.After disassembly of the product it was found that the ball bearings have been stiff and the push button had a groove worn into it on the inner side.This shows that it has been depressed while the instrument was in use and is usually a sign that it has been used to lift soft tissue away from the treatment area.This causes unusual friction and hence heat up of the product.Also the worn ball bearing cause increase of temperature due to higher friction.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 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 pushbutton 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

The dental assistant informed during a phone call that on (b)(6) 2017 while performing crown prep to tooth# 14 & 19, the patient felt the handpiece heat up that felt uncomfortable on lower lip.No mark shown on lip.Some vaseline has been applied to lip, but no medical care was necessary.Further details about patient have not been supplied.

• Brand Name: EXPERTTORQUE LUX E679 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, bw 88400 ; GM 88400
• MDR Report Key: 7132868
• MDR Text Key: 95848138
• Report Number: 3003637274-2017-00075
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: E679 L
• Device Catalogue Number: 1.006.9200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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