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

Catalog Number	V041113000000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 21 cfr 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 is reported that a raypex 6 gave incorrect measurements.No injury.
Additional Manufacturer Narrative
Siroforce no.(b)(4).Touch without function.Sent in parts: measuring cable file clamp repair report: the device has been repaired and checked according to manufacturer specifications.Please charge the device before use.The repair was carried out according to the diagnostic report.We have reviewed your repair request; the repair was carried out under warranty / goodwill.Parts and services used for repair: vr01113000900 raypex 6 display and enclosure 1.000.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

• Brand Name: RAYPEX 6
• Common Device Name: 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: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 23819114
• Report Number: 9611053-2025-00176
• Device Sequence Number: 18658708
• Product Code: LQY
• UDI-Device Identifier: E225V8411130000001
• UDI-Public: E225V8411130000001
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K131907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Device Catalogue Number: V041113000000
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/10/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown