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

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

The analysis did show that the bearings have been gritty and the handpiece ran out of specification.But the heat up was not reproducible during a test run.According to dental nurse the handpiece has been used as cheek retractor.The condition of the bearings is a result of the normal wear process which takes place during the use.The root cause for the heat up is the use as cheek retractor.In this case the push button gets pressed while the bur is rotating.This causes unusual inner friction and therefore a quick heat up of the head.(b)(4).Kavo dental (b)(4) (the manufacturer) is submitting the report on behalf of kavo dental usa (the importer).

• 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: 3938561
• MDR Text Key: 18031368
• Report Number: 3003637274-2014-00022
• 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

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other