BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6'

    MDR report key: 24430332 · Received February 24, 2026

    Report

    Report Number
    2424472-2026-00574
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Report Date
    February 24, 2026
    Manufacturer
    DENTSPLY LLC
    Product Code
    EAP
    UDI-DI
    D0031000086240
    PMA / PMN Number
    K093453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. USB 3 FIRMWARE V1.4 CONTAINS AN ISSUE IN THE PORTION OF CODE USED TO OPTIMIZE SENSOR PERFORMANCE. IF THE OPTIMIZATION OCCURS DURING AN EXPOSURE OR SENSOR READOUT, THERE IS A CHANCE THAT THE RESULTING IMAGE WILL BE CORRUPTED. IMAGE DATA FOLLOWING THE POINT OF CORRUPTION WILL CONSIST OF DATA THAT WAS PREVIOUSLY HELD IN THE MEMORY OF THE USB DEVICE. AS A RESULT, THE PRESENTED IMAGE MAY CONTAIN A PORTION OF DATA FROM A PREVIOUS EXPOSURE. IN GENERAL, THIS WOULD BE OBVIOUS TO THE USER SINCE THE PRESENTED IMAGE WOULD EITHER CONTAIN OBVIOUS ARTIFACTS OR DIFFERENT ANATOMY THAN EXPECTED. FIELD SERVICE EVALUATION- PROBLEM DESCRIPTION (B)(6) 2026, 10:24:50 , (B)(6). INITIAL LOG (B)(6) 2026 9:58:28 AM (B)(6). WARRANTY: YES (DATE OF MANUFACTURER 10/27/2025) DEALER ON-SITE: NO BILLABLE: NO BILLING ACCEPTED: NA BILLING APPROVED BY: NA 90 DAY EXPIRATION DATE: 05/11/2026. REMOTE ACCESS: YES WORKSTATION(S): (B)(4). TROUBLESHOOTING DESCRIPTION: (B)(6) CALLED IN REQUESTING HELP WITH SENSOR CONNECTIVITY ISSUES AND X-RAYS BEING DUPLICATED. IT WAS DISCOVERED THE USB INTERFACES MOVE ROOMS SINCE THEY HAVE 3 INTERFACES AND 6 OPERATORIES. THE PROBLEM FOLLOWS ONE INTERFACE. THIS IS NOT THE ORIGINAL CAPA REFERRING TO OLD PATIENT / NEW PATIENT. WHAT HAPPENS IS AN X-RAY IS TAKEN IN ONE TEMPLATE SQUARE, AND THAT SAME IMAGE IS DUPLICATED / REPRODUCED IN THE NEXT TEMPLATE SQUARE. RETAKE IMAGES HAVE BEEN TAKEN WHEN THIS ISSUE OCCURS. (1 ADDITIONAL IMAGE PER PATIENT) PATIENT WAS INVOLVED, AND NO PATIENT INJURY OCCURRED. THIS INTERFACE (S/N: (B)(6) DUPLICATES IMAGES EVERY X-RAY DURING OUR TESTING. IT'S THE ONLY INTERFACE HAVING THIS ISSUE, OTHERS ON THE SAME COMPUTER WITH THE SAME USB CABLE PLUGGED INTO THE SAME USB PORT WORKS FINE. RECOMMENDING REPLACING THIS INTERFACE UNDER WARRANTY.

    Description of Event or Problem · 0

    WHILE THE CUSTOMER WAS USING A PART OF AN INTRAORAL SENSOR SYSTEM, SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6', THEY ALLEGE EXPERIENCING IMAGE QUALITY ISSUES WHEN AN X-RAY IMAGE WAS TAKEN AND AN ADDITIONAL IMAGE WAS REQUIRED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200680 SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6' UNIT, X-RAY, INTRAORAL EAP DENTSPLY LLC D0031000086240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown