MAUDE Adverse Event Report: KAVO DENTAL GMBH GENTLEPOWER LUX CONTRA ANGLE 25LPR; DENTAL HANDPIECE

Model Number 25LPR

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

During a standard dental treatment on tooth 22 and 23 the handpiece heated up and caused a burn inside the lip.The burn had approximately the size of the back cap of the handpiece.The pt was advised to use ice cubes and take otc 800mg ibuprofen as needed.

Manufacturer Narrative

The analysis did show that the head of the handpiece head dent which caused the push button to stick in.This caused unusual internal friction which caused the head to heat up.In addition the ball bearings of the head drive have been worn which also supports the increase of temperature.This is the result of normal wear process, it might be that due to the higher temperature due to the sticking push button the bearing had a stronger wear.The user instruction requires a visual and functional test prior to each treatment to ensure that the handpiece runs within specifications.Reported due to the 2 year presumption rule.

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPR
• 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: 3813444
• MDR Text Key: 4371745
• Report Number: 3003637274-2014-00013
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25LPR
• Device Catalogue Number: 1.007.3580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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: 28 YR