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

Catalog Number AEU-25

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

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 Description

In this event it was reported that an aseptico dtc endo motor displayed an error message, and was used in a case where a file broke; the patient was referred to an endodontist to complete treatment.

Manufacturer Narrative

*motor m4b-46184* replaced the broken rotor magnet.

• Brand Name: ASEPTICO ENDO DTC MOTOR
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city, tn
• MDR Report Key: 10431868
• MDR Text Key: 204371936
• Report Number: 2320721-2020-00112
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• PMA/PMN Number: K030163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AEU-25
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1