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

Catalog Number PMKEM1

Device Problems No Audible Alarm (1019); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

In this event it was reported a promark endo motor was not beeping warning for too much torque; no injury resulted.

• Brand Name: PROMARK ENDODONTIC MOTOR
• Type of Device: HANDPIECE, DIRECT DRIVE, AC-POWERED
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): ASEPTICO, INC; 8333 216th st se; woodinville WA 98072
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 12727864
• MDR Text Key: 281011626
• Report Number: 2320721-2021-00086
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMKEM1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1