BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK CUTTING FORCEPS, 5MM, 33CM

    MDR report key: 5040231 · Received August 28, 2015

    Report

    Report Number
    2951238-2015-00407
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    GYRUS ACMI INC,
    Product Code
    GEI
    PMA / PMN Number
    K142759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THE REPORT WAS DISCARDED AFTER USE IN THE PROCEDURE. THEREFORE, NO DEVICE WILL BE RETURNED TO OLYMPUS FOR INVESTIGATION. THE INSTRUCTION MANUAL WARNS USERS "PRE-TEST THE DEVICE TO VERIFY COMPLETE ELECTRICAL ACTIVITY AND GENERATOR SETTING. INSUFFICIENT GENERATOR OUTPUT TIME OR GENERATOR OUTPUT LEVEL MAY NOT PROVIDE THE OPERATOR WITH THE DESIRED LEVEL OF COAGULATION."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE PATIENT SUFFERED EXCESSIVE BLEEDING AT THE UTERINE ARTERIAL SITE. THE BLEEDING WAS CONTROLLED BY SEALING THE AREA MULTIPLE TIMES WITH THE CUTTING FORCEPS. NO BLOOD PRODUCTS WERE REQUIRED. IT WAS REPORTED THAT THE SURGEON BEGAN THE PROCEDURE AT THE FALLOPIAN TUBES AND WOULD SEAL TWICE EVERY TIME BEFORE HE CUT. THE DEVICE BLADE WAS ADVANCED AND THE TISSUE SPREAD APART WITH MINIMAL BLEEDING AT THE TIP OF THE DEVICE. THE BLEEDING WAS RESOLVED BY SEALING AGAIN WITH THE CUTTING FORCEPS. AS THE PROCEDURE PROGRESSED TO THE BROAD LIGAMENTS THE TISSUE WAS PULLED FARTHER APART TO CREATE TENSION, THE SURGEON WOULD AGAIN SEAL TWICE AND THEN ADVANCE THE BLADE. THE BLEEDING BECAME SIGNIFICANT WITH EVERY SINGLE CUT, ESPECIALLY AT THE TIP OF THE DEVICE. AT THIS TIME THE GENERATOR WAS SET TO DEFAULT SETTINGS AND EFFECT 3. THE INTENDED PROCEDURE WAS COMPLETED VAGINALLY WITH THE SAME DEVICE. THE PATIENT WAS DISCHARGED HOME THE SAME DAY. THE DEVICE WAS NOT INSPECTED OR TESTED PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572473 PK CUTTING FORCEPS, 5MM, 33CM PK CUTTING FORCEPS GEI GYRUS ACMI INC, PK-CF0533 JF950993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention