BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ CALCUTRIPT

    MDR report key: 40421 · Received September 27, 1996

    Report

    Report Number
    2020550-1996-00024
    Event Type
    Injury
    Date Received
    September 27, 1996
    Date of Event
    August 27, 1996
    Report Date
    September 26, 1996
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    FFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER A CYSTOSCOPY BLADDER STONE FRAGMENTING PROCEDURE WHILE THE PT WAS STILL UNDER GENERAL ANESTHETIC, IT WAS NOTED THAT THE PT HAD A DISTENDED ABDOMEN. CYSTOGRAM WAS PERFORMED AND REVEALED PERFORATION AT POSTERIOR BLADDER WALL. LAPAROTOMY WAS PERFORMED TO REPAIR PERFORATION. SMALL PORTION OF BLADDER CALCULUS RETRIEVED FROM RETROPERITONEAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CALCUTRIPT ELECTRO HYDRAULIC LITHOTRIPTOR FFK KARL STORZ GMBH & CO. 27080C *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention