BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATABLE OSTIUM PUNCH

    MDR report key: 1368616 · Received April 17, 2009

    Report

    Report Number
    1418479-2009-00006
    Event Type
    Malfunction
    Date Received
    April 17, 2009
    Date of Event
    February 19, 2009
    Report Date
    April 17, 2009
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KTF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL # CATALOG # THE 8211.661 IS THE FORCEPS ATTACHMENT FOR THE 8211.651 ROTATABLE PUNCH. ENDUSER REPORTED MODEL # 8211.661 AND CATALOG # 8211.611. DEVICE EVALUATED BY MANUFACTURER: RICHARD WOLF HAS NOT SEEN THE PUNCH THAT WAS REPORTED AS BROKEN AND INVOLVED IN AN INCIDENT. AT THIS TIME THE ENDUSER DOES NOT KNOW THE DISPOSITION OF THE PUNCH. THE PUNCH WAS NOT RECEIVED BY RICHARD WOLF AS A REPAIR. AT THIS TIME THERE IS NO INFO PERTAINING TO ANY INCIDENT PROVIDED BY THE ENDUSER TO RICHARD WOLF. IF SUCH INFO IS PROVIDED AT A LATER DATE, A FOLLOW-UP TO FDA WILL BE DONE.

    Description of Event or Problem · 1

    IT WAS REPORTED AS A MAUDE EVENT REPORT (FOI) BY THE ENDUSER TO FDA THAT A WOLF SINUS INSTRUMENT BACK BITING RONGEUR BROKE OFF IN PT'S RIGHT MAXILLARY SINUS CAVITY. THE BROKEN PIECE WAS RETRIEVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1