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

Model Number 25 LPA

Device Problems Device Issue (2379); Dent in Material (2526)

Patient Problem Burn, Thermal (2530)

Event Date 04/15/2015

Event Type  Injury  

Event Description

During a standard dental treatment, the handpiece heated up and caused one burn on the lower right lip and one burn inside the corner of the cheek.The burn diameters have been double the size of the back cap.Patient was prescribed ibuprofen 600mg and steroid medrol pack for the burns.Patient received also otc vitamine e oil to apply to burns.

Manufacturer Narrative

The analysis of the product showed that the bearings have been gritty, the chuck system has been worn out and the head had a dent at the push button.The condition of the bearings and the chuck system is the result to the normal wear process.Both could already cause an increase of temperature.The major problem was the dent which caused the back cap to stick in, causing unusual inner friction and therefore heat up of the head.The dent shows that the handpiece received a strong hit (e.G.Dropping).To avoid such issues the user instruction contains several warnings and notes: 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 pushbutton 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).

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPA
• Type of Device: DENTAL ELECTRICAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 8840 0; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 8840 0; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400 ; 735156
• MDR Report Key: 4846546
• MDR Text Key: 18028722
• Report Number: 3003637274-2015-00012
• Device Sequence Number: 1
• Product Code: EKX
• 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: 06/16/2015,05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 25 LPA
• Device Catalogue Number: 1.002.1526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2015
• Distributor Facility Aware Date: 05/28/2015
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 05/28/2015
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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 Outcome(s): Other
• Patient Age: 14 YR