MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC MOTOR:ASEPTICO DTC; HANDPIECE, DIRECT DRIVE, AC-POWERED

Catalog Number	AEU-25
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that motor:aseptico dtc was auto reversing too quickly and is inconsistent with error messages.No injury.
Additional Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
Investigation completed.Opening comments by vivian: it randomly reverses and they are unable to calibrate the unit.Closing comments: motor m4b-44300* found stator winding opened; replaced stator assy.All tested ok.Console* replaced overlay, updated software to tul06, tested ok.Foot pedal* tested ok.Pwr cord* tested ok.Fyi-a stator is the stationary component found in electric motors and generators.It consists of a laminated core and coils of insulated wire known as the windings.When alternating current is applied to a stator, it creates a rotating magnetic field.

• Brand Name: MOTOR:ASEPTICO DTC
• Common Device Name: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 20064916
• Report Number: 2320721-2024-00051
• Device Sequence Number: 20793438
• Product Code: EKX
• UDI-Device Identifier: 10817417020821
• UDI-Public: 10817417020821
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K030163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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 Catalogue Number: AEU-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown