MAUDE Adverse Event Report: DENTSPLY VDW GMBH RAYPEX 6 APEX LOCATOR; LOCATOR, ROOT APEX

Catalog Number V041113000000

Device Problems Incorrect Measurement (1383); Device Operates Differently Than Expected (2913)

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

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received where this malfunction in a similar device 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 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 a raypex 6 apex locator gave incorrect measurements; no injury resulted.

Manufacturer Narrative

Apex locator and apex-stop function checked with calibration box (b)(4) without errors.Complete check without errors.

• Brand Name: RAYPEX 6 APEX LOCATOR
• Type of Device: LOCATOR, ROOT APEX
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• Manufacturer (Section G): FORUM ENGINEERING TECHNOLOGIES (96) LTD.; 1 platin str.; new industrial zone; rishon lezion hamerkaz, 75653 39; IS 7565339
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5808318
• MDR Text Key: 50824869
• Report Number: 9611053-2016-00034
• Device Sequence Number: 1
• Product Code: LQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V041113000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2017
• 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: Unknown
• Patient Sequence Number: 1