BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEECLEAR XCL

    MDR report key: 3732816 · Received March 28, 2014

    Report

    Report Number
    3732816
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 28, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FCZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH ROBOTIC ASSISTED AND BILATERAL SALPINGO-OOPHORECTOMY, CYSTOSCOPY. DURING THE PROCEDURE THE SMOKE EVACUATION TUBING HAD SUB-OPTIMAL SMOKE EVACUATION, DELAYING THE PROCEDURE UNTIL SMOKE CLEARED FROM THE ABDOMINAL CAVITY. PER STAFF, "IT TOOK A LONG TIME AND THE PRODUCT DOES NOT WORK WELL". UNSURE OF EXACT AMOUNT OF TIME. WE HAVE HAD REPEATED ISSUES WITH THE PRODUCT ACCORDING TO OUR STAFF. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185294 SEECLEAR XCL TUBE, SMOKE REMOVAL, ENDOSCOPIC FCZ COOPERSURGICAL, INC. * 147344

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR