BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE OSTIUM PUNCH

    MDR report key: 294164 · Received August 29, 2000

    Report

    Report Number
    1418479-2000-00052
    Event Type
    Malfunction
    Date Received
    August 29, 2000
    Date of Event
    July 28, 2000
    Report Date
    July 31, 2000
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KTF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SINUS SURGERY WAS IN PROGRESS WHEN TWO (2) SMALL PIECES OF THE OSTIUM PUNCH BROKE OFF IN THE NASAL CAVITY. THE SURGEON WAS ABLE TO RETRIEVE ONE BROKEN PIECE. THE OTHER FRAGMENT IRRIGATED OUT. NO PT CONSEQUENCES WERE REPORTED AND NO ADDITIONAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATABLE OSTIUM PUNCH OSTIUM PUNCH KTF RICHARD WOLF GMBH 8211.661 P679159

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR