BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATCLAVE G4 CHAMBER AUTOCLAVE

    MDR report key: 20866944 · Received December 6, 2024

    Report

    Report Number
    8043629-2024-00001
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 6, 2024
    Manufacturer
    SCICAN LTD.
    Product Code
    FLE
    PMA / PMN Number
    K190062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION H4: ON 03-NOV-2025, IT WAS IDENTIFIED THAT ADVERSE EVENT REPORT 8043629-2024-00001 WHICH WAS INITIALLY REPORTED 06-DEC-2024, CONTAINED AN ERROR IN SECTION H4. THE DEVICE MANUFACTURE DATE WAS INCORRECTLY RECORDED AS 09-FEB-2014. THE CORRECT DATE, CONSISTENTLY NOTED THROUGHOUT THE REMAINDER OF THE INITIAL REPORT, HAS NOW BEEN UPDATED TO ACCURATELY REFLECT 09-FEB-2023. ALL OTHER INFORMATION REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 0

    CHRONOLOGICAL DATES OF ACTIONS/EVALUATIONS/SERVICE: FEB 2023: THE UNIT WAS PRODUCED AND DELIVERED TO DEALER, AND THEN TO THE END USER (A DENTAL OFFICE). AUG. 2023: THE END USER RETURNED THE UNIT TO THE DEALER DUE TO THE FAILURE THAT THE DOOR WAS NOT LOCKED, BUT THE ICON ON THE UNIT WAS INDICATING THAT IT WAS LOCKED (DESCRIPTION FROM DEALER "DOOR IS UNLOCKED - LOCKING ICON IS FLASHING"). AUG 2023: THE DEALER TECHNICIAN REACHED OUT TO SCICAN TECHNICAL SERVICE FOR ASSISTANCE. WITH ASSISTANCE FROM SCICAN TECHNICAL SERVICE (ON THE PHONE) THE DOOR LOCKING MECHANISM WAS ADJUSTED AND THE UNIT WAS RETURNED TO THE CUSTOMER. OCT 17 2024: THE UNITS CYCLES STARTED TO TAKE LONGER (STERILIZATION TIME IS UNAFFECTED, BUT THE TIME TO PRESSURIZE THE UNIT WAS TAKING LONGER) UNTIL THE UNIT EVENTUALLY STOPPED THE CYCLE, INDICATING CYCLE FAULT #4 (CF#4: FAILURE TO PRESSURIZE). THE END USER CONTACTED THE DEALER FOR SERVICE. OCT 18 2024: THE UNIT WAS DELIVERED TO SCICAN FROM THE DEALER FOR SERVICE AND ROUTINE CALIBRATION. NOV 7 2024: SCICAN TECHNICIAN SET UP THE UNIT FOR A LEAK TEST AND THE FAILURE DESCRIBED ABOVE OCCURRED. NOV 7 2024 - DEC 5 2024: SCICAN ENGINEERING AND REGULATORY AFFAIRS SPOKE WITH THE SCICAN TECHNICIAN INVOLVED WITH THE 'PRODUCT PROBLEM' TO OBTAIN THE DETAILS OF WHAT HAPPENED AND ENGINEERING STARTED THEIR INVESTIGATION. THE SERVICE HISTORY OF THE UNIT WAS ALSO REQUESTED (WHICH IS INCLUDED IN THE ACTIONS ABOVE). THE RECORD OF TRAINING PERFORMED BY SCICAN TECHNICAL SERVICE FOR THE DEALER THAT SERVICED THE UNIT WAS CHECKED AND THE TECHNICIAN WHO PERFORMED THE SERVICE WAS NOT TRAINED BY SCICAN (4 OTHER TECHNICIANS WERE TRAINED IN AUGUST 2020). ALL TESTING, EVALUATION AND APPROVALS (E.G. ASME AND CRA APPROVALS) DEMONSTRATES THAT IF THE MECHANISM IS SERVICED AND ADJUSTED CORRECTLY, THIS FAILURE WON'T OCCUR AS THE DOOR HANDLE SHAFT CAN NEVER MOVE OUT OF ALIGNMENT OVER TIME FROM IT'S INSTALLED POSITION.

    Description of Event or Problem · 0

    A STATCLAVE STERILIZER WAS RETURNED TO SCICAN FROM ONE OF OUR DEALERS FOR ADDITIONAL SERVICE AS THEIR TECHNICIAN WAS UNABLE TO RESOLVE THE ISSUE THAT THEIR CUSTOMER RETURNED THE UNIT FOR. BEFORE PERFORMING ANY OTHER ACTIONS, A SCICAN TECHNICIAN PERFORMED A ROUTINE PRESSURE TEST (TO IDENTIFY ANY LEAKS). TO PERFORM THIS TEST THE DOOR WAS CLOSED AND THE LOCK BUTTON WAS PRESSED. THE DOOR HANDLE WAS CONFIRMED TO BE IN THE "CLOSED" POSITION, AND 2 OF THE 3 MICROSWITCHES (DCL AND DLK) WERE OBSERVED TO BE IN THE "ON" POSITION, INDICATING THAT THE DOOR WAS LOCKED (A THIRD MICROSWITCH, DLA, WAS NOT CONFIRMED TO BE INDIVIDUALLY CHECKED BY THE TECHNICIAN BEFORE RUNNING THE COMPRESSED AIR TEST). COMPRESSED AIR WAS CONNECTED TO THE UNIT THE UNIT WAS PRESSURIZED (WHILE THE DEVICE WAS COOL). WHEN THE PRESSURE REACHED APPROXIMATELY 165-170 KPA, A LOUD POP WAS HEARD AND THE DOOR SUDDENLY OPENED TO APPROXIMATELY 50 DEGREES FROM ITS CLOSED POSITION. THE TECHNICIAN PERFORMING THE TEST WAS STANDING AT THE SIDE OF THE UNIT, AWAY FROM THE DOOR, AND WAS NOT HARMED. CHRONOLOGICAL DATES OF ACTIONS/EVALUATIONS/SERVICE: FEB 2023: THE UNIT WAS PRODUCED AND DELIVERED TO DEALER, AND THEN TO THE END USER (A DENTAL OFFICE). AUG. 2023: THE END USER RETURNED THE UNIT TO THE DEALER DUE TO THE FAILURE THAT THE DOOR WAS NOT LOCKED, BUT THE ICON ON THE UNIT WAS INDICATING THAT IT WAS LOCKED (DESCRIPTION FROM DEALER "DOOR IS UNLOCKED - LOCKING ICON IS FLASHING"). AUG 2023: THE DEALER TECHNICIAN REACHED OUT TO SCICAN TECHNICAL SERVICE FOR ASSISTANCE. WITH ASSISTANCE FROM SCICAN TECHNICAL SERVICE (ON THE PHONE) THE DOOR LOCKING MECHANISM WAS ADJUSTED AND THE UNIT WAS RETURNED TO THE CUSTOMER. OCT 17 2024: THE UNITS CYCLES STARTED TO TAKE LONGER (STERILIZATION TIME IS UNAFFECTED, BUT THE TIME TO PRESSURIZE THE UNIT WAS TAKING LONGER) UNTIL THE UNIT EVENTUALLY STOPPED THE CYCLE, INDICATING CYCLE FAULT #4 (CF#4: FAILURE TO PRESSURIZE). THE END USER CONTACTED THE DEALER FOR SERVICE. OCT 18 2024: THE UNIT WAS DELIVERED TO SCICAN FROM THE DEALER FOR SERVICE AND ROUTINE CALIBRATION. NOV 7 2024: SCICAN TECHNICIAN SET UP THE UNIT FOR A LEAK TEST AND THE FAILURE DESCRIBED ABOVE OCCURRED. NOV 7 2024 - DEC 5 2024: SCICAN ENGINEERING AND REGULATORY AFFAIRS SPOKE WITH THE SCICAN TECHNICIAN INVOLVED WITH THE 'PRODUCT PROBLEM' TO OBTAIN THE DETAILS OF WHAT HAPPENED AND ENGINEERING STARTED THEIR INVESTIGATION (PLEASE SEE THE ATTACHED REPORT). THE SERVICE HISTORY OF THE UNIT WAS ALSO REQUESTED (WHICH IS INCLUDED IN THE ACTIONS ABOVE). THE RECORD OF TRAINING PERFORMED BY SCICAN TECHNICAL SERVICE FOR THE DEALER THAT SERVICED THE UNIT WAS CHECKED AND THE TECHNICIAN WHO PERFORMED THE SERVICE WAS NOT TRAINED BY SCICAN (4 OTHER TECHNICIANS WERE TRAINED IN AUGUST 2020). ALL TESTING, EVALUATION AND APPROVALS (E.G. ASME AND CRA APPROVALS) DEMONSTRATES THAT IF THE MECHANISM IS SERVICED AND ADJUSTED CORRECTLY, THIS FAILURE WON'T OCCUR AS THE DOOR HANDLE SHAFT CAN NEVER MOVE OUT OF ALIGNMENT OVER TIME FROM IT'S INSTALLED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622989 STATCLAVE G4 CHAMBER AUTOCLAVE STEAM STERILIZER FLE SCICAN LTD. G4-621101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown