BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTIUM PUNCH BACKWARD BITING FORCEPS

    MDR report key: 255653 · Received December 17, 1999

    Report

    Report Number
    1418479-1999-00054
    Event Type
    Malfunction
    Date Received
    December 17, 1999
    Date of Event
    November 19, 1999
    Report Date
    November 19, 1999
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KTF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BLADE OR JAW OF AN OSTIUM PUNCH FORCEPS BROKE OFF DURING SINUS SURGERY. THE SMALL METAL PIECE WAS RETRIEVED. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTIUM PUNCH BACKWARD BITING FORCEPS OSTIUM PUNCH BACKWARD BITING FORCEPS KTF RICHARD WOLF GMBH 8211.08 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR