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

Catalog Number V041113000000

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Raypex 6 provided incorrect measurements, 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 results are not available as of this report.Evaluation results will be submitted as they become available.Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.

Event Description

It has been reported that a complaint from a customer experienced inaccurate measurements while using a raypex 6.No further information is available at this time.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: RAYPEX 6
• Type of Device: LOCATOR, ROOT APEX
• Manufacturer (Section D): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer (Section G): VDW GMBH; bayerwaldstrasse 15; munich bayern 81737 ; GM 81737
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 12933617
• MDR Text Key: 283322904
• Report Number: 9611053-2021-00426
• Device Sequence Number: 1
• Product Code: LQY
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V041113000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2021
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1