ELECTROTORQUE PLUS 25LPA 1002.1526

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-09-27 for ELECTROTORQUE PLUS 25LPA 1002.1526 manufactured by Kavo Dental.

Event Text Entries

[21255972] A dentist reported that a patient received a burn to his cheek during the use of a 25lpa handpiece. The patient was prescribed kenalog in orabase to treat the patient's burn. It was reported that the patient has recovered.
Patient Sequence No: 1, Text Type: D, B5


[21345236] The actual unit involved in the incident was returned for evaluation. It was observed that the had dents at the 1 and 9 o'clock positions on the water faceplate and at the 1 and 10 o'clock positions on the back end cap. It was observed that the head, insert, drive assembly and cover nut are all damaged due to the multiple dents in the head. The unit was disassemble for further inspection. It was observed that the bearings and shaft in the drive assembly are worn and gritty due to the multiple dents. A high amount of debris was also observed in the handpiece. During a follow up call with the dental office by the manufacturer, it was reported that the handpiece may not have been maintained according to the manufacturer's recommendations. It was reported that the handpiece is not cleared of debris until after the unit has been removed from the autoclave. The dental office was advised that performing this practice may cause the debris to become baked inside the handpiece. The office was reeducated as to the proper maintenance of the handpiece and was provided with maintenance instructions. A cautionary statement is included with each unit which states that electric micromotors generate significantly more power than traditional air turbines and air motors. Due to increased torque and speed, poorly maintained, damaged or misused handpieces can potentially generate frictional heat capable of causing serious burn injuries to the patient. It also states that the head of the attachment should not be used as a cheek or tongue retractor.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1419798-2006-00002
MDR Report Key766022
Report Source05,07
Date Received2006-09-27
Date of Report2006-08-28
Date of Event2006-08-21
Date Mfgr Received2006-08-28
Device Manufacturer Date2004-07-01
Date Added to Maude2006-10-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJOHN MILLER, DIR
Manufacturer Street901 WEST OAKTON STREET
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone8473643931
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELECTROTORQUE PLUS
Generic NameELECTRIC DENTAL HANDPIECE
Product CodeEKK
Date Received2006-09-27
Returned To Mfg2006-09-13
Model Number25LPA
Catalog Number1002.1526
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key753882
ManufacturerKAVO DENTAL
Manufacturer Address340 E. MAIN ST. LAKE ZURICH IL 60047 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-09-27

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