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

Model Number 200XDR

Device Problems Device Maintenance Issue (1379); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 07/11/2017

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.After disassembling of the product it was found that the ball bearings have been worn out and gritty.This causes higher friction and hence increase of temperature.In addition there have been groove marks visible at the inner side of the push button.This indicates that it has been pressed while the tool was spinning.This again causes higher friction and hence increase of temperature.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 push button 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

During a dental endo and crown prep of tooth# 26 and 30, patient was burned on right corner of lip.Burned diameter was size of handpiece head.Office applied over the counter oxyfresh gel to lip.No medical care necessary.As dental office was not able to identify which product caused the burn a second handpiece was sent in for analysis.As both handpieces are in the same condition it is not possible to assign the incident to one of both.Therefore a second mdr is issued for the same burn but with the second handpiece.See also mdr #3003637274-2017-00047.

• 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: 6783878
• MDR Text Key: 82331782
• Report Number: 3003637274-2017-00046
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2013
• 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: 70 YR