BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2139625 · Received June 18, 2011

    Report

    Report Number
    9610617-2011-00025
    Event Type
    Other
    Date Received
    June 18, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 16, 2011
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SEMI-RIGID SCOPE HAS BROKEN LIGHT FIBERS RESULTING IN INADEQUATE VISUALIZATION CAPABILITY. THE EYEPIECE IS LEAKING, THE CABLE IS LEAKING AT WHERE IT IS ATTACHED TO THE SCOPE. THE IMAGE BUNDLE AS WELL AS THE LIGHT BUNDLE WERE COMPROMISED BY THE LEAK.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A SIALOENDOSCOPY PROCEDURE, DOCTOR STATED SCOPE VISUALIZATION WAS INADEQUATE, SO HE PROCEEDED WITH AN OPEN PROCEDURE AND REMOVED A SALIVARY GLAND THAT HE FELT HE HAD TO REMOVE ANYWAY. PATIENT CONDITION POST OP WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ SIALENDOSCOPY TELESCOPE FBP KARL STORZ GMBH & CO. KG 11573A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other