BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1373217 · Received April 25, 2009

    Report

    Report Number
    9610617-2009-00013
    Event Type
    Other
    Date Received
    April 25, 2009
    Date of Event
    March 27, 2009
    Report Date
    April 24, 2009
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    FBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THIS SCOPE HAD A BENT SHAFT, 50% BROKEN LIGHT FIBERS, AND IMAGE BUNDLE HAD SEPARATION FROM THE OBJECTIVE LENS. CONDITION OF SCOPE IS CONSISTENT WITH DAMAGE CAUSED BY OVER-TORQUING. WE HAVE NO OTHER COMPLAINTS INVOLVING THIS SCOPE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A SIALENDOCHOPLASTY PROCEDURE, THE SCOPE LENS CRACKED AND HE LOST VISUALS; DOCTOR HAD A BACKUP SCOPE, BUT CLAIMS IT WOULD HAVE TAKEN TOO LONG TO STERILIZE, SO HE SWITCHED TO AN OPEN PROCEDURE TO COMPLETE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ MINI SIALENDOSCOPY 0 DEGREES TELESCOPE FBP KARL STORZ GMBH & CO. KG 11574A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other