BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ

    MDR report key: 3193513 · Received June 20, 2013

    Report

    Report Number
    MW5030675
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 20, 2013
    Manufacturer
    KARL STORZ
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) WOMAN HAD UNCOMPLICATED LAPAROSCOPIC HYSTERECTOMY FOR FIBROIDS UTERUS. DURING MORCELLATION, PNEUMOPERITONEUM WAS LOST FOR UNCLEAR REASON. WHILE TRYING TO TROUBLESHOOT AND RESTORE PNEUMOPERITONEUM, THE FOOT PEDAL OF THE MORCELLATOR WAS INADVERTENTLY ACTIVATED BY AN ASSISTANT. AFTER PNEUMOPERITONEUM WAS RESTORED, A 2 CM SMALL BOWEL ENTEROTOMY WAS NOTED. GENERAL SURGERY WAS CONSULTED, CONVERTED LAPAROSCOPIC CASE TO LAPAROTOMY DID SMALL BOWEL RESECTION. PT RECOVERED WITHOUT COMPLICATIONS. I WOULD SUGGEST THAT STORZ CHANGES ITS PRODUCT TO HAVE HAND-CONTROLLED, NOT FOOT CONTROLLED ACTIVATION, OR THAT ALTERNATIVE PRODUCTS - BLUEENDO, LINA, GYNECARE- ARE USED FOR MORCELLATION DUE TO SAFETY FEATURES STORZ DOES NOT HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281484 STORZ LAPAROSCOPIC MORCELLATOR HET KARL STORZ

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization