BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY CUTTING LOOP

    MDR report key: 1077563 · Received July 16, 2008

    Report

    Report Number
    MW5007673
    Event Type
    Injury
    Date Received
    July 16, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 16, 2008
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA INC
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING HYSTEROSCOPY WITH A STORZ CUTTING LOOP. THE TIP OF THE LOOP BROKE OFF WHILE DOING THE PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PT THROUGH THE HYSTEROSCOPE WITHOUT INJURY TO THE PT. DATES OF USE: ONE TIME USE: 2008. DIAGNOSIS OR REASON FOR USE: INTRACAVITARY MASS WITHIN THE UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY CUTTING LOOP CUTTING LOOP DIAM:0.35MM/24 FR FAS KARL STORZ ENDOSCOPY AMERICA INC 34444

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability