BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2496457 · Received March 15, 2012

    Report

    Report Number
    9610617-2012-00009
    Event Type
    Other
    Date Received
    March 15, 2012
    Date of Event
    November 21, 2011
    Report Date
    March 13, 2012
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP REPORTED THAT DOCTOR TORQUED SCOPE, AND THE LENS CRACKED. SCOPE EVAL CONFIRMED THAT SCOPE HAD BROKEN ROD LENSES.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A TUR OF BLADDER TUMOR, DOCTOR INSERTED SCOPE IN URETHRA AND TORQUED IT WHILE POSITIONING THE SCOPE, AND THE LENS CRACKED. HE HAD NO FURTHER VISUALIZATION AND HAD TO ABORT THE PROCEDURE. PROCEDURE WAS RESCHEDULED FOR A LATER DATE AND WAS COMPLETED WITH NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ HOPKINS TELESCOPE GCJ KARL STORZ GMBH & CO. KG 27325BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other