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

Model Number 25 LPA

Device Problems Overheating of Device (1437); Dent in Material (2526); Physical Resistance/Sticking (4012)

Patient Problem Burn, Thermal (2530)

Event Date 05/19/2020

Event Type  malfunction  

Manufacturer Narrative

The analysis prior to the repair showed that the product was running out of specification at >600ma instead of 150ma.During a short test run the heat up was reproducible.From outside it was visible that the head of the product had a dent which caused the push button to stick in, causing higher friction and hence heat up.The dent is the result of a strong external force, e.G.A drop.It was also recognized that the bearings have been vibrating during the test run.After disassembling it got also visible that the bearings have been worn out as the result of wear and tear.It got also visible that the push button had a groove worn into it due to rubbing on drive.This confirms that it stuck in during the use of the product.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: risk of burn injury from hot handpiece head or hot handpiece lid.Burn injuries in the mouth may be caused if the handpiece overheats.Never touch soft tissue with the handpiece head or handpiece lid! 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! the following individuals are authorized to repair and service kavo products: technicians at kavo branches throughout the world.Technicians specially trained by kavo.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.Service may only be carried out by kavo-trained repair shops using original kavo replacement parts.(b)(4).

Event Description

During a crown preparation to teeth # 28/29/30 the patient was burned which caused a blister on lip.Medical care was not necessary, patient applied a unknown ointment.

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPA
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 10178822
• MDR Text Key: 197138580
• Report Number: 3003637274-2020-00011
• Device Sequence Number: 1
• Product Code: EGS
• 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: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/22/2020

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: 25 LPA
• Device Catalogue Number: 1.002.1526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2004
• 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: 60 YR