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

Catalog Number PMKEM1

Device Problems Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where calibration failure of a similar device 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 results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it was reported that when calibrating a promark endo motor, there are "weird" symbols displaying on the unit.The event outcome is unknown as of this mdr evaluation.However, there is no indication that injury resulted.Additional information is being requested.

Manufacturer Narrative

The device software was found to be corrupt.The software was updated and passed specification testing.

Manufacturer Narrative

Additional information was received indicating there was no injury to the patient.

• 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: 5339493
• MDR Text Key: 35254265
• Report Number: 2320721-2015-00026
• 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,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• 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: 02/23/2016
• 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