BEUDAMED
    FDA Adverse Event Other Summary report: N

    STORZ-GERMANY

    MDR report key: 159576 · Received March 24, 1998

    Report

    Report Number
    159576
    Event Type
    Other
    Date Received
    March 24, 1998
    Date of Event
    July 15, 1997
    Report Date
    November 20, 1997
    Manufacturer
    STORZ
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A LITHOLAPAXY; AFTER STONE IN THE BLADDER WAS CRUSHED, THE LITHOTRITE SHAFT ROTATED CAUSING AN INABILITY TO REALIGN AND REMOVE IT. IT THEN BECAME NECESSARY TO PERFORM AN OPEN PROCEDURE. THE SURGEON HAD CHECKED THE INSTRUMENT BEFORE THE LITHOLAPAXY BEGAN AND DID NOT TIGHTEN THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ-GERMANY LITHOTRITE FFK STORZ * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other