MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRAMATIC LUX CONTRA ANGLE 25 LS; DENTAL HANDPIECE

Model Number 25 LS

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

During a standard dental treatment the handpiece got hot and burned the patient on lip.The burn was treated with some otc ointments.No medical care was necessary.

Manufacturer Narrative

The analysis did show that the gear rim was shifted and the bearings of the drive have been defect.Both indicates that the handpiece has been dropped with a inserted drill.In this case the drive receives via the inserted drill a strong hit which causes the shift of the gear rim and also the damage of the bearings.The user instruction states that only fault free products should be used.A visual and function inspection test prior to each treatment is mandatory.Reported due to the 2 year presumption rule.Event occurred in (b)(6) and is reported as a similar product gets sold in the usa.

• Brand Name: INTRAMATIC LUX CONTRA ANGLE 25 LS
• 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: 3777692
• MDR Text Key: 4436708
• Report Number: 3003637274-2014-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K073478
• 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: 12/11/2013

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 25 LS
• Device Catalogue Number: 0.553.5260
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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