BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2446368 · Received February 3, 2012

    Report

    Report Number
    9610617-2012-00004
    Event Type
    Other
    Date Received
    February 3, 2012
    Date of Event
    January 5, 2012
    Report Date
    February 3, 2012
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIXED JAW IS BROKEN OFF. DAMAGE MAY BE DUE TO OVERSTRESS/MECHANICAL OVERLOAD OF INSTRUMENT.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DR WAS PERFORMING A PROCEDURE TO REMOVE THE MENISCUS WHEN THE FIXED JAW OF THE FORCEPS BROKE OFF INTO PT. THE DR EXPERIENCED DIFFICULTIES IN RETRIEVING BROKEN JAW; IT TOOK HIM AN HOUR TO REMOVE PIECE. HE THEN REPLACED INSTRUMENT AND COMPLETED PROCEDURE. THE HOSP REPORTED THAT THE RETRIEVAL PROCESS HAD NO ADVERSE IMPACT ON PT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ GRASPER KOG KARL STORZ GMBH & CO. KG 28171HC AC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other