BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3009244 · Received March 12, 2013

    Report

    Report Number
    9610617-2013-00009
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 11, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE JAWS OF THE BIOPSY FORCEPS ARE STUCK IN OPEN POSITION; POSSIBLE DAMAGE TO THE DRAW BAR DUE TO STRESS OVERLOAD. WE SHOW NO OTHER COMPLAINTS FOR THIS ISSUE WITH THIS PRODUCT.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A VENTRICULAR BIOPSY AND WHEN SHE SENT TO GRASP TISSUE, THE JAWS WOULD NOT CLOSE. THE DOCTOR EXPERIENCED DIFFICULTIES IN REMOVING THE INSTRUMENT THAT ADDED AN HOUR TO THE PROCEDURE. INSTRUMENT WAS REPLACED AND PROCEDURE COMPLETED. PATIENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104782 KARL STORZ BIOPSY FORCEPS FCL KARL STORZ GMBH & CO. KG 11161KA TY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other