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	08/30/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
In this event it is reported that motor: aseptico dtc was auto reversing too quickly.No injury.
Additional Manufacturer Narrative
Repair evaluation performed by aseptico.See attached.Opening comments by vivian: the unit keeps reversing while in use.Closing comments: *console* replaced the overlay; tested okay.*motor m4b-44432* replaced the cable and both bearings; tested okay.*pwr cord* and *foot pedal* tested okay.

• 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: 20134156
• Report Number: 2320721-2024-00053
• Device Sequence Number: 12586877
• Product Code: EKX
• UDI-Device Identifier: 10817417020821
• UDI-Public: 10817417020821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/12/2024

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: 08/30/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown