BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1904425 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06908
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 17, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HYSTEROSCOPY SCOPE WAS DISCOVERED TO BE MALFUNCTIONING IMMEDIATELY BEFORE IT WAS USED ON THE PATIENT. PATIENT WAS ALREADY UNDER ANESTHESIA. THERE WAS NO BACK-UP SCOPE BECAUSE THE SECOND SCOPE MALFUNCTIONED THE WEEK BEFORE AND WAS OUT FOR REPAIR. THE PROCEDURE WAS ABORTED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE SCOPE HAD BEEN RUN THROUGH ITS NORMAL (AND LENGTHY) PRIMING AND CALIBRATING PROCEDURE WITH CIRCULATING NURSE. WHEN THE SURGEON PICKED UP THE SCOPE IN PREPARATION TO USE IT, ONE PIECE SEPARATED FROM ANOTHER. THE SCOPE THEN BEGAN TO LEAK SALINE ON DR.'S PANTS. THE SALINE WAS AT ROOM TEMPERATURE. THERE WAS NOTHING THAT COULD BE DONE TO FIX THE SCOPE. THE PROCEDURE WAS ABORTED. WHEN THE SCOPE WAS TAKEN APART ALL THE WAY, THE DELICATE METAL O-RING WAS FOUND TO BE DISCONNECTED FROM THE SCOPE AND IT WAS SPLIT. THE SCOPE WAS THEN BROUGHT TO SURGICAL STERILE PROCESSING DEPARTMENT. THE SCOPE WAS TAKEN OUT OF OPERATION. BECAUSE OF SIMILAR PROBLEMS WITH THE SECOND SCOPE, WHICH WAS OUT FOR REPAIR AT THE TIME, IT WAS DECIDED THAT THE MOST PRUDENT COURSE WAS TO PURCHASE TWO NEW SCOPES. AS STATED IN AN EARLIER REPORT ON THE SAME ISSUE. THIS PATIENT WILL NEED TO RETURN FOR A SECOND ANESTHESIA FOR THE PROCEDURE THAT WAS ABORTED.

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE MULTICLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS WIT107

    Patients

    Seq Age Sex Outcome Treatment
    1