MAUDE Adverse Event Report: KAVO DENTAL GMBH COMFORTDRIVE 200XDR DENTAL ELECTRICAL HANDPIECE

Model Number 200XDR

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

During a test run of the product the heat up was reproducible and it showed that the handpiece was running out of specification as it needed a too high current. This is a sign that the bearings are not running smooth anymore due to wear process. In addition it was found that the push button has groove marks on the inner side. This shows that it has been pressed while the handpiece has been spinning. This causes unusual friction and hence a quick heat up of the head. To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: 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

Dr. (b)(6) on (b)(6) 2017 stated while working tooth# 1, 2, and 3 on (b)(6) 2017 during teeth extraction procedure, patient was burned on right cheek and right side of tongue. Burn diameter to cheek was quarter in size and size of dime on tongue. Patient was given an over the counter ointment. No medical care necessary.

• Brand Name: COMFORTDRIVE 200XDR
• Type of Device: DENTAL ELECTRICAL 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 ; 735156
• MDR Report Key: 6607504
• MDR Text Key: 76504849
• Report Number: 3003637274-2017-00037
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080677
• 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: 06/02/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 200XDR
• Device Catalogue Number: 1.007.3570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse