BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAPAROSCOPIC NEEDLE HOLDER

    MDR report key: 41250 · Received September 13, 1996

    Report

    Report Number
    1418479-1996-00005
    Event Type
    Other
    Date Received
    September 13, 1996
    Date of Event
    August 13, 1996
    Report Date
    August 14, 1996
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A LAPAROSCOPIC NEEDLE HOLDER WAS BEING CLEANED WHEN A COMPONENT OF THE GRASPING JAW WAS NOTED TO BE MISSING. THE DEVICE WAS LAST USED IN A LAPAROSCOPY-ASSISTED VAGINAL HYSTERECTOMY. THE FRAGMENT, APPROX 3.8 MM X 7.1 MM IN SIZE, MAY HAVE BEEN LOST IN THE PT, BUT NO EVIDENCE HAS BEEN FOUND TO DATE. USER FACILITY BELIEVES THE PIECE WAS POSSIBLY LOST DURING THE CLEANING AND HANDLING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC NEEDLE HOLDER NEEDLE HOLDER FHQ RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8383.533 151J3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other