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

Model Number 25LPA

Device Problem Overheating of Device (1437)

Patient Problems Swelling (2091); Burn, Thermal (2530)

Event Date 11/20/2013

Event Type  malfunction  

Event Description

During a root canal treatment on the right side of the mouth the head of the handpiece heated up and caused a blister from burns on the upper right cheek.It has approximately the size of a dime.Dental office applied some otc topical anesthetic gel and gave the patient some of that gel to apply later.

Manufacturer Narrative

The analysis did show that the head had a dent at the back cap button.This caused the back cap button to stick in, interfering with the internal moving parts.This caused high friction and therefore increase of temperature.In addition the bearings have been gritty and hence they also supported the increase of temperature.The dent shows that the handpiece received a strong hit, e.G.Dropping during reprocessing.The condition of the bearings is the result of the normal wear process.The user instruction requires a visual and functional test prior to each treatment to ensure that the handpiece is running within specification.Reported due to the 2 year presumption rule.

• Brand Name: GENTLEPOWER 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: 3777666
• MDR Text Key: 4441923
• Report Number: 3003637274-2014-00003
• 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: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25LPA
• Device Catalogue Number: 1.002.1526
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/18/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• 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: 46 YR