BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSTEROSCOPIC HOOK SCISSORS

    MDR report key: 275929 · Received April 28, 2000

    Report

    Report Number
    1418479-2000-00023
    Event Type
    Malfunction
    Date Received
    April 28, 2000
    Date of Event
    March 28, 2000
    Report Date
    March 29, 2000
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HRR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOOK SCISSORS BEING USED FOR HYSTEROSCOPY BROKE AND SOME SMALL METAL PIECE OF THE JAW CAME OFF IN THE UTERUS. IT IS BELIEVED THE PIECES WERE IRRIGATED OUT AT THE COMPLETION OF THE CASE. NO METAL FRAGMENTS WERE RECOVERED FROM THE IRRIGANT. THERE WERE NO PT PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYSTEROSCOPIC HOOK SCISSORS HYSTEROSCOPIC HOOK SCISSORS HRR RICHARD WOLF GMBH 8642.681 P665320

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN