BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUR WIRE LITHOTRIPTOR BASKET

    MDR report key: 218614 · Received April 9, 1999

    Report

    Report Number
    9680909-1999-00001
    Event Type
    Malfunction
    Date Received
    April 9, 1999
    Date of Event
    March 24, 1999
    Report Date
    April 1, 1999
    Manufacturer
    GIP MEDIZINTJECHNIK GMBH
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, BASKET WAS LOCATED JUST BELOW CYSTIC DUCT. THE 1MM OR SLIGHTLY LARGER, HARD STONE WAS LOADED INSIDE THE BASKET. THE CRANK OF THE HANDLE WAS TURNED 2 OR 3 REVOLUTIONS WHEN THE BASKET CABLE FRACTURED UNDER THE METAL SPIRAL AT THE DISTAL END OF THE HANDLE. THE FACILITY'S STAFF MANUEVERED THE BASKET AND RELEASED THE STONE; THEN REMOVED THE BASKET FROM THE PATIENT BY HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUR WIRE LITHOTRIPTOR BASKET 30 MM, 26MM DIAMETER (STONE CRUSHING) LQC GIP MEDIZINTJECHNIK GMBH 82278 9711187

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other