BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1632534 · Received March 9, 2010

    Report

    Report Number
    3001770034-2010-00006
    Event Type
    Other
    Date Received
    March 9, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 8, 2010
    Manufacturer
    KARL STROZ GMBH & CO KG
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WELD WAS COMPROMISED AND THE 1.5" TIP CAME OFF THE END OF THE BLADE. WE HAVE NO OTHER REPORTS OF THIS OCCURRING. WE ARE RETURNING THIS INSTRUMENT TO THE MFR FOR FURTHER EVAL.

    Description of Event or Problem · 1

    ALLEGEDLY, MIDWAY THROUGH A HYSTERECTOMY PROCEDURE, THE TIP CAME OFF THE END OF THE BLADE INTO THE PT. DOCTOR USED A GRASPER TO RETRIEVE; IT FELL OUT OF THE GRASPER ONCE, AND THEN DOCTOR GRASPED IT AGAIN AND REMOVED IT FROM THE PT. HE REPLACED THE BLADE AND COMPLETED THE PROCEDURE WITH NO IMPACT ON PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ MORCELLATOR CUTTER HET KARL STROZ GMBH & CO KG 091112-01 966940

    Patients

    Seq Age Sex Outcome Treatment
    1 Other