BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1359365 · Received March 24, 2009

    Report

    Report Number
    2020550-2009-00008
    Event Type
    Other
    Date Received
    March 24, 2009
    Date of Event
    February 23, 2009
    Report Date
    March 20, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DOCTOR WAS PERFORMING A PERCUTANEOUS NEPHROSCOPY; WHEN HE USED THE INSTRUMENT TO REMOVE FRAGMENTED STONES, ONE LEG OF THE THREE-PRONG GRASPER BROKE OFF IN PT. DOCTOR USED X-RAY TO CONFIRM PIECE WAS IN PT BUT COULD NOT GET VISUALIZATION OF WHERE IT WAS; HE COMPLETED PROCEDURE WITHOUT RETRIEVING THE BROKEN PIECE. IN 2009, THE DOCTOR PERFORMED ANOTHER NEPHROSCOPY TO FRAGMENT REMAINING STONES; HE TOOK THAT OPPORTUNITY TO REMOVE BROKEN PIECE. PROCEDURE COMPLETED; THERE WAS NO ADVERSE PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ GRASPING FORCEPS GEN KARL STORZ GMBH & CO. KG 27290H DD

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other