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

Catalog Number	PMKEM1
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that during treatment customer was using promark endo motor, the customer indicated that the patient jumped when the rotary file entered both the canals in tooth number 13.Dr finished the procedure with hand files, and obturated with no complications.Dr suspects it could have been a shock, as there were no issues when hand filing, no root tissue to cause the pain.No patient injury.
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr 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 results: evaluation performed by aseptico.See attached report.Console: replaced the +48v power supply and cables; tested the unit for current leakage by the engineering department and tested okay.Motor m250t-12556: replaced the connector and front bearing; tested okay.Foot pedal: and the pwr cor.

• Brand Name: PROMARK ENDO MOTOR
• 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: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18170910
• Report Number: 2320721-2023-00283
• Device Sequence Number: 12710966
• Product Code: EKX
• UDI-Device Identifier: D716PMKEM11
• UDI-Public: D716PMKEM11
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111078
• 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): 12/07/2023

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: PMKEM1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown