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

Model Number 25LPR

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Dentist informed that in (b)(6) 2014 during a standard dental treatment the handpiece heated up and caused a burn on tongue with the size of 10 mm x 5 mm.This was not mentioned when the handpiece had been sent in for repair in (b)(6) 2014.As there have been questions afterwards the dentist called now in (b)(6) 2014 and gave us the info about the burn.Pt did not receive any medication and did fully heal.

Manufacturer Narrative

The analysis did not show that the handpiece had a high debris level.This indicates that the maintenance is not performed as requested.It also showed that the bearings have been vibrating, grinding and falling apart.The high debris level causes high friction within the bearings and hence an increase of temp and also a stronger wear than usual.As a wear process is normal for the spinning parts a service check on a regular basis is recommended.

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25 LPR
• 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: 4321023
• MDR Text Key: 5134407
• Report Number: 3003637274-2014-00037
• 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: 11/06/2014

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: 25LPR
• Device Catalogue Number: 1.007.3580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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: 78 YR