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

Model Number 25 LPR

Device Problems Overheating of Device (1437); Physical Resistance/Sticking (4012)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

A short visual inspection and a test run prior to the repair showed that the heat up was reproducible.Root cause has been that the ball bearings have been worn out which caused grinding and as a result vibrations and higher friction and hence heat up.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: warning: hazards for the care provider and the patient.In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held.Do not use further and notify service.Caution: burning hazard from hot instrument head or hot instruments cover.If the instrument overheats, burns may arise in the oral area.Never contact soft tissue with the instrument head or instrument cover.The following guidelines must be observed to ensure save use of the electrically driven contra-angle handpieces: the service instructions for contra-angle handpieces must be precisely following when using kavo spray or quattrocare care systems.Before each use, the contra-angle handpiece must be checked for external damage.Before each use, perform a test run with the contra-angle handpiece, and watch for atypical heating and unusual noise and vibration.Immediately stop using contra-angle handpieces that act unusual.Never press the push-button during operation.This also includes lifting the cheek or tongue! to ensure proper function, the medical device must be set up according to the reprocessing methods described in the kavo instructions for use, and the care products and care systems described therein must be used.Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.This service interval depends on the frequency of use and should be adjusted accordingly.(b)(4).

Event Description

When product was sent in it was just stated that instrument gets hot and burns patient.Up to now a contact to the dental office was not possible to get further data.

Event Description

Finally, it was possible to get a feedback from the dental office.During a dental treatment the head of the handpiece heated up and burned the patient on inner cheek.There was no medical care necessary.

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• MDR Report Key: 10458789
• MDR Text Key: 204526721
• Report Number: 3003637274-2020-00016
• Device Sequence Number: 1
• Product Code: EGS
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25 LPR
• Device Catalogue Number: 1.007.3580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1