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

Catalog Number PMKEM1

Device Problem Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); Insufficient Information (4580)

Event Type  malfunction  

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.

Event Description

In this event it was reported that a patient felt an "electrical shock" while the clinician was using a promark motor; no injury resulted.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• 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
• MDR Report Key: 10760284
• MDR Text Key: 215291368
• Report Number: 2320721-2020-00151
• Device Sequence Number: 1
• Product Code: EKX
• Combination Product (y/n): N
• PMA/PMN Number: K111078
• 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: 10/30/2020
• 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
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1