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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W & H DENTALWERK MOTOR WITH CABLE
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W & H DENTALWERK MOTOR WITH CABLE Back to Search Results
Catalog Number 04720022
Device Problem Overheating of Device (1437)
Patient Problem No Information (3190)
Event Date 08/24/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the motor (04720022) unit was overheating.It was also reported that they were not able to complete the procedure.Patient went home with the injury, as there were no other units in the office.
 
Manufacturer Narrative
One motor unit was returned to the manufacturer (w&h) for evaluation.A visual inspection revealed that the cable and bearing were worn out.The plug sleeve was physically broken.Presence of water was found inside the motor as well as debris on the contact pins.The malfunction was confirmed by the manufacturer.A root cause cannot be determined.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
MOTOR WITH CABLE
Type of Device
MOTOR
Manufacturer (Section D)
W & H DENTALWERK
ignaz-glaser-strafte 53
5111 burmoos
MDR Report Key7899988
MDR Text Key121437925
Report Number0001038806-2018-00827
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 09/21/2018,02/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04720022
Device Lot Number01390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2018
Was the Report Sent to FDA? No
Date Report Sent to FDA09/21/2018
Distributor Facility Aware Date02/04/2019
Event Location Other
Date Report to Manufacturer08/29/2018
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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