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

Catalog Number PMKEM1

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Shock (2072); Electric Shock (2554)

Event Date 03/13/2018

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

It was reported that a patient felt an electrical shock during use of a promark endo motor; no intervention was required.

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): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): ASEPTICO, INC; 8333 216th st se; woodinville WA 98072
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 7426245
• MDR Text Key: 105531587
• Report Number: 2320721-2018-00018
• 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: 06/05/2018

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 Operator: Health Professional
• Device Catalogue Number: PMKEM1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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