BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPAROSCOPIC INJECTION NEEDLE

    MDR report key: 6812812 · Received August 23, 2017

    Report

    Report Number
    MW5071751
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    August 10, 2017
    Report Date
    August 21, 2017
    Manufacturer
    RICHARD WOLF MEDICAL
    Product Code
    GAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED ON (B)(6) 2017 FOR LAPAROSCOPIC INTRAFASCIAL HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY. DURING THE COURSE OF INJECTING IN AND AROUND THE CERVIX WITH LOCAL AND EPINEPHRINE, THE LAPAROSCOPIC 22 GAUGE NEEDLE BROKE. THE SURGEON ATTEMPTED TO FIND NEEDLE FRAGMENT; HOWEVER, HE WAS NOT ABLE TO VISUALLY IDENTIFIED IT. F/U X-RAY SHOWED THAT THE OBJECT OF INTEREST HAD MIGRATED EVEN HIGHER INTO THE ABDOMEN, WAS UNDER THE DIAPHRAGM. ON (B)(6) 2017, PT RETURNED TO OPERATING ROOM FOR SUCCESSFULLY REMOVAL OF NEEDLE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595431 LAPAROSCOPIC INJECTION NEEDLE LAPAROSCOPIC INJECTION NEEDLE GAA RICHARD WOLF MEDICAL RCHW NUMBER 8383.60

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention