BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEP

    MDR report key: 170096 · Received May 27, 1998

    Report

    Report Number
    MW1013870
    Event Type
    Malfunction
    Date Received
    May 27, 1998
    Date of Event
    May 12, 1998
    Report Date
    May 12, 1998
    Manufacturer
    ELMED, INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PROCESS OF TAKING BIOPSY FROM LEFT OVARY, BIOPSY GRASPING FORCEP BROKE. JAW OF FORCEPS WOULD NOT CLOSE. AFTER TAKING FORCEPS OUT OF PT, IT WAS EXAMINED AND A SMALL PIECE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASPING FORCEP BIOPSY FORCEP FOR LAPAROSCOPIC PROCEDURES KNW ELMED, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other