BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2141356 · Received June 14, 2011

    Report

    Report Number
    9610617-2011-00024
    Event Type
    Other
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 10, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SEMI-RIGID FIBERSCOPE AND THE SHAFT OF THE SCOPE WAS BENT CAUSING DAMAGE TO INTERNAL FIBERS RESULTING IN A POOR IMAGE. DOCTOR EXAMINED SCOPE PRE-PROCEDURE AND WAS AWARE THAT SCOPE WAS BENT; DOCTOR PROCEEDED WITH CASE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A SALIENDOSCOPY PROCEDURE, DOCTOR STATED SCOPE VISUALIZATION WAS INADEQUATE SO HE ABORTED THE PROCEDURE. PATIENT EXHIBITED SWELLING OF CHEEK AT THE END OF THE PROCEDURE. DOCTOR WILL RESCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ SALIENDOSCOPY TELESCOPE FBP KARL STORZ GMBH & CO. KG 11576 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other