BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2163728 · Received July 7, 2011

    Report

    Report Number
    9610617-2011-00027
    Event Type
    Other
    Date Received
    July 7, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 30, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    EZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL SENT A PICTURE SHOWING THE INSTRUMENT WITH THE BLADE BROKEN OFF; IT APPEARS THAT MISSING PIECE IS ABOUT 2CM IN LENGTH. THE HOSPITAL IS NOT RELEASING THE COLD KNIFE. CORRECTION: I SUBMITTED THIS MDR TO THE FDA AT THE END OF JUNE. THE YEAR LISTED IN THE MANUFACTURING AND UF/DISTRIBUTOR REPORTING NUMBERS WAS INCORRECT. I LISTED NUMBERS AS: 9610617-2010-00027, 2020550-2010-00027. THE CORRECT NUMBERS ARE: 9610617-2011-00027, 2020550-2011-00027.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A CYSTOSCOPY, THE TIP OF THE KNIFE BROKE OFF IN PT. DOCTOR WAS UNABLE TO RETRIEVE; DOCTOR STATED HE THOUGHT PIECE WOULD PASS THROUGH PT WITH NO IMPACT. PROCEDURE COMPLETED AND PT CONDITION POST OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ COLD KNIFE EZO KARL STORZ GMBH & CO. KG 27069K UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other