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

Model Number 25LPR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  No Answer Provided  

Event Description

The product was sent in for repair with the statement that patient was burned during treatment, up to now it was not possible to reach the corresponding person in the dental office to get further details about the issue.Hence it is not possible to supply the missing data about the patient and the event.This data will be supplied with a follow up report.

Manufacturer Narrative

The analysis did show that the handpiece has been running out of specification.During a test run the heat up was reproducible.After disassembling of the head, cleaning of the parts and reassembling, the heat up was not reproducible anymore.Therefore, we currently assume that too much lubricant inside the handpiece caused the heat up.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.A follow up report will be supplied as soon as the missing data are available.

• 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: 3865684
• MDR Text Key: 19588294
• Report Number: 3003637274-2014-00017
• 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: 04/25/2014

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: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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