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

Catalog Number	V041113000000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Event or Problem Description
In this event it was reported that a raypex 6 apex locator gave incorrect measurements.The event outcome is unknown as of this mdr evaluation.
Additional Manufacturer Narrative
Battery (voltage breaks under load) defect.Additional information received indicating no injury occurred.

• Brand Name: RAYPEX 6 APEX LOCATOR
• Common Device Name: LOCATOR, ROOT APEX
• Manufacturer (Section D): DENTSPLY VDW GMBH; bayerwaldstrasse 15; munich, 81737 ; GM 81737
• MDR Report Key: 8404973
• Report Number: 9611053-2019-00039
• Device Sequence Number: 2053963
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: V041113000000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1