MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRAMATIC LUX3 CONTRA ANGLE 25LHA; DENTAL HANDPIECE

Model Number 25LHA

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

The product has been tested and analysed prior to the repair.The visual inspection did not show any deviations.The test run showed that the product was running completely out of specification: current consumption was far too high due to stiff running bearings.The heat up was reproducible.After disassembling of the product, it got visible that inside the handpiece was a high debris level.This causes higher friction and hence heat up.Root cause is that the maintenance is not done as requested by ifu.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: 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).

Event Description

During a crown prep to tooth# 30, the patient was burned on cheek about a quarter in size.Patient was prescribed norco 10mg of pain medication.

• Brand Name: INTRAMATIC LUX3 CONTRA ANGLE 25LHA
• 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: 8618822
• MDR Text Key: 145345795
• Report Number: 3003637274-2019-00019
• 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: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 25LHA
• Device Catalogue Number: 0.553.5350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2019
• Distributor Facility Aware Date: 04/22/2019
• Device Age: 17 YR
• Event Location: Other
• Date Report to Manufacturer: 04/22/2019
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2001
• 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: 58 YR