BEUDAMED
    FDA Adverse Event Other Summary report: N

    GYN FORCEPS

    MDR report key: 3599468 · Received January 23, 2014

    Report

    Report Number
    MW5034043
    Event Type
    Other
    Date Received
    January 23, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 20, 2014
    Manufacturer
    OLYMPUS
    Product Code
    HCZ
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014: FEMALE PT WHO UNDERWENT OUTPATIENT LAPAROSCOPIC TUBAL LIGATION, DILATION AND CURETTAGE AND HYSTEROSCOPY, NOVASURE AND REMOVAL OF PARAGARD INTRAUTERINE DEVICE (IUD). AFTER MULTIPLE REPEATED/UNSUCCESSFUL ATTEMPTS TO REMOVE THE IUD, SURGEON DECIDED TO USE AN OPERATIVE SCOPE AND GRASPER TO OBTAIN IUD. IN THE PROCESS OF "GRABBING IT" WITH THE GRASPER, A PORTION OF THE TIP (APPROX 0.5 CM X 2.7.) OF THE GRASPER BROKE AND WAS WITHIN THE PT. XRAY WAS OBTAINED AND CONFIRMED THAT THE TIP/METAL PIECE REMAINED IN PT'S UTERUS. UTILIZING A HYSTEROSCOPY THE METAL TIP WAS FOUND AND REMOVED FROM PT. SURGERY WAS COMPLETED AND PT SENT TO RECOVERY ON (B)(6) 2013 - POST RECOVERY PT WAS DISCHARGED HOME IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55536 GYN FORCEPS SEMI-RIGID ALLIGATOR GRASPER HCZ OLYMPUS GYA 5

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other