BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ ENT CABINET

    MDR report key: 144092 · Received January 14, 1998

    Report

    Report Number
    1920664-1998-00024
    Event Type
    Malfunction
    Date Received
    January 14, 1998
    Date of Event
    January 5, 1998
    Report Date
    January 6, 1998
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    ETF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMPNER AND HOSE ATTACHMENT WERE RECEIVED ON 02/24/1998. THERE WAS A VISIBLE KINK IN THE HOSE NEAR THE FITTING THAT IS THREADED INTO THE DAMPNER. IT IS POSSIBLE THAT THE HOSE FITTING MAY HAVE BEEN OVER-TORQUED TO REMOVE THE KINK WHICH MAY HAVE STRESSSED OR WEAKENED THE CAP. THE INSPECTION RECORD FOR THIS CABINET INDICATES AN INSPECTION DATE OF 11/06/1994 AND THAT IT HAD BEEN SOLD TO A CUSTOMER IN SAN ANTONIO, TX. THERE ARE NO REQUESTS FOR SERVICE ON THIS CABINET.

    Description of Event or Problem · 1

    TECHNICIAN INVESTIGATED REPORT OF LACK OF VACUUM AND PRESSURE IN CABINET. WAS LAST INSPECTED 8/29/97. WHEN TURNED ON PRESSURE PUMP 2 1/2 INCH DIAMETER PLASTIC PRESSURE VESSEL SCHEDULE 30 "PVC" PIPE EXPLODED UNDER APPROXIMATELY 120 PSI PRESSURE. POSSIBLE THAT TUBING WAS CRIMPED. THE END CAP FRAGMENTED. ACCORDING TO COMPANY CURRENT PRODUCTION OF THIS ITEM USES A SMALLER STAINLESS STEEL PRESSURE VESSEL. PLAN IS TO REPLACE THESE PARTS ON OTHER CABINETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ ENT CABINET ENT CABINET ETF STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO