BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1318096 · Received January 16, 2009

    Report

    Report Number
    2020550-2009-00001
    Event Type
    Other
    Date Received
    January 16, 2009
    Date of Event
    December 15, 2008
    Report Date
    January 15, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GDF
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR COMPLETED A LAP COLON RESECTION. DOCTOR DID NOT SEE ANYTHING COME OFF ANY INSTRUMENT DURING PROCEDURE. THE NEEDLE HOLDER WAS EXAMINED AFTER PROCEDURE PRE-DISINFECTION/STERILIZATION, AND FOUND TO BE MISSING DISTAL TIP OF INSIDE JAW. DOCTOR INFORMED PATIENT, AND TOLD HIM THAT THE PIECE (5-7MM IN LENGTH, 3.5MM THICK), PRESENTED NO RISK DUE TO SMALL SIZE. PATIENT ELECTED NOT TO HAVE AN X-RAY. THE HOSPITAL COULD NOT CONFIRM WHETHER INSTRUMENT WAS USED OR WHETHER A PIECE CAME OFF DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ NEEDLE HOLDER GDF KARL STORZ GMBH & CO. KG 26173KL LG

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other