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

Catalog Number	V041113000000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that a raypex 6 apex locator gave incorrect measurements.Doctor reported the connection between the probe and the host becomes loose.The equipment displayed a sudden drift in values, which remained inaccurate even after multiple calibrations, resulting in excessive preparation of the canal and causing swelling and pain around the patient's periapical area.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.Investigation summary potential root causes may be wear items and excessive use, lack in knowledge of the user, treatment errors (f.Ex too dry or too wet canals or not using a rubber dam), patient conditions (f.Ex calcification, canal anatomy), quality issues, maintenance issue (f.Ex exchange wear items regularly, no calibration/cable test), misuse (f.Ex broken usb socket, drop of device).In addition, there are further circumstances on the conditions in dentistry (f.Ex training/knowledge status), or any other environmental conditions (f.Ex electrical interference), which are unknown to us and may also have an impact on the reported failure mode.Correlation between adverse event and the involved medical devices: indeterminate: the important information of adverse event is incomplete or unavailable, and the cause of adverse events of medical devices cannot be determined.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: 23728243
• Report Number: 9611053-2025-00172
• Device Sequence Number: 21135030
• Product Code: LQY
• UDI-Device Identifier: E225V8411130000001
• UDI-Public: E225V8411130000001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: V041113000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/28/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown