BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2588426 · Received May 17, 2012

    Report

    Report Number
    9610617-2012-00016
    Event Type
    Other
    Date Received
    May 17, 2012
    Date of Event
    April 17, 2012
    Report Date
    May 15, 2012
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP OF THE KNIFE IS BROKEN OFF; IT IS APPROXIMATELY 7MM IN LENGTH. CONTACT AT HOSPITAL STATED THEY BELIEVED IT BROKE DUE TO THE DENSITY AND HARDNESS OF THE SEPTUM BONE. CONDITION OF INSTRUMENT IS CONSISTENT WITH DAMAGE CAUSED BY MECHANICAL OVERLOAD. THIS IS THE ONLY REPORT OF BREAKAGE OF THIS INSTRUMENT THAT WE HAVE RECEIVED.

    Description of Event or Problem · 1

    ALLEGEDLY, THE TIP OF THE SICKLE KNIFE BROKE OFF IN THE PT'S NASAL PASSAGE DURING AN ENT PROCEDURE; THE TIP FELL DOWN THE PT'S THROAT. THE DOCTOR PERFORMED A LARYNGOSCOPY AND RETRIEVED THE PIECE WITH A GRASPER. HE WENT ON TO COMPLETE ORIGINAL PROCEDURE; ONLY A MINOR DELAY CAUSED AND THERE WAS NO IMPACT ON PT. PT CONDITION POST OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ SICKLE KNIFE KTG KARL STORZ GMBH & CO. KG 628002 BI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other