MAUDE Adverse Event Report: DENTSPLY VDW GMBH PROMARK APEX LOCATOR; LOCATOR, ROOT APEX

Catalog Number	PMKAL1
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The pcb and housing needed replaced.
Event or Problem Description
In this event it was reported that a promark apex locator gave incorrect measurements; no injury occured.

• Brand Name: PROMARK APEX LOCATOR
• Common Device Name: LOCATOR, ROOT APEX
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 8395869
• Report Number: 9611053-2019-00031
• Device Sequence Number: 14956417
• Product Code: LQY
• Combination Product (Y/N): N
• PMA/510(K) Number: K131907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: PMKAL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1