BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS OMNI

    MDR report key: 3038605 · Received March 28, 2013

    Report

    Report Number
    3038605
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 28, 2013
    Manufacturer
    GYRUS AMCI. INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO GYRUS OMNI HAND PIECES DID NOT FUNCTION CORRECTLY DURING A PROCEDURE. THE FIRST ONE- THE TIP BROKE BUT REMAINED ATTACHED. THE SECOND ONE EXHIBITED WEAK POWER AND SWITCHED TO BIPOLAR KLEPPINGER. THERE WAS NO HARM TO THE PATIENT. BOTH DEVICES HAD THE SAME LOT NUMBER AND EXPIRATION DATES. NOTES FROM THE OPERATIVE REPORT: "EXTENSIVE LYSIS OF ADHESIONS WAS INITIATED WITH A GYRUS. IT REQUIRED TWO GYRUS DEVICES DUE TO THE PRESSURES ON THE GYRUS JAWS, ONE SET OF JAWS WAS COMPROMISED REQUIRING A SECOND GYRUS WHICH WILL BE SENT BACK TO THE COMPANY. BOWEL WAS DENSELY ADHERENT REQUIRING A VERY DELICATE DISSECTION. CAUTERY SCISSORS WERE ALSO NECESSARY."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC-ASSISTED TOTAL VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, EXTENSIVE LYSIS OF SEVERE PELVIC AND BOWEL ADHESIONS, REMOVAL OF LARGE CERVICAL FIBROID.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127397 PKS OMNI ELECTROSURGICAL GEI GYRUS AMCI. INC. 5MM/33CM MK517194

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR