BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYPEX 6

    MDR report key: 23728243 · Received December 5, 2025

    Report

    Report Number
    9611053-2025-00172
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 27, 2025
    Report Date
    January 27, 2026
    Manufacturer
    VDW GMBH
    Product Code
    LQY
    UDI-DI
    E225V8411130000001
    PMA / PMN Number
    K131907
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913042 RAYPEX 6 LOCATOR, ROOT APEX LQY VDW GMBH E225V8411130000001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown