MAUDE Adverse Event Report: KAVO DENTAL GMBH GENTLE LUX CONTRA ANGLE 25LPA; DENTAL HANDPIECE

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

Please refer to importer report # (b)(4).

Manufacturer Narrative

The analysis did show that the bearings have been gritty and the handpiece ran out of specification.The heat up was reproducible during a test run.Due to this condition there is a higher friction during the rotation and hence the bearings and therefore the head is heating up.The condition of the bearings is a result of the wear process which takes place during the use.The user instruction requires a visual and functional test prior to each treatment to ensure that the handpiece is running within specification.(b)(4).

• Brand Name: GENTLE LUX CONTRA ANGLE 25LPA
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach 88400 ; GM 88400 ; 351561356
• MDR Report Key: 3610680
• MDR Text Key: 4091481
• Report Number: 3003637274-2014-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/13/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1