MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRAMATIC LUX CONTRA ANGEL 25 LHA; DENTAL HANDPIECE

Model Number 25 LHA

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

During a standard dental treatment the handpiece got hot and burned the pt on lip.The burn was slightly larger than a pea per dental office.The burn was treated with some otc ointments.No medical care was necessary.Dental office does not recall the patients name, hence it is not possible to supply patients age.

Manufacturer Narrative

The analysis did show that the bearings have been grinding.Also the water spray has been clogged and the bur guide has been broke.The handpiece has not been serviced since 2007.The heat up was reproducible during a short test run.All findings beside the clogged water spray are the result of the normal wear process.The worn bearings cause a higher friction and hence a increase of temperature, the clogged water spray causes also a reduced cooling of the handpiece.The user instruction states that only fault free products should be used.A visual and functional inspection test prior to each treatment is mandatory.Reported dude to the 2 year presumption rule.

• Brand Name: INTRAMATIC LUX CONTRA ANGEL 25 LHA
• 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: 3745920
• MDR Text Key: 4222469
• Report Number: 3003637274-2014-00006
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/23/2013

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 LHA
• Device Catalogue Number: 0.553.5350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2003
• 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