BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3081051 · Received March 29, 2013

    Report

    Report Number
    1221826-2013-00012
    Event Type
    Other
    Date Received
    March 29, 2013
    Manufacturer
    KARL STORZ ENDOVISION, INC.
    Product Code
    FFS
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIGHT CABLE WAS EVALUATED AND WHILE THERE WERE SOME DENTS AND NICKS FOUND, THESE DID NOT AFFECT FUNCTIONALITY. HEAT OUTPUT AND LIGHT TRANSMISSION TESTS SHOWED IT WAS WELL WITHIN SPECIFICATIONS. THE DOCTOR WAS USING A LIGHT CABLE THAT WAS TOO LARGE IN DIAMETER FOR THE SCOPE IT WAS ATTACHED TO AND HAD THE LIGHT SOURCE SET AT 100% INTENSITY. THIS CAUSED SCOPE TO OVERHEAT RESULTING IN MINOR PATIENT BURN.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131268 KARL STORZ LIGHT CABLE FFS KARL STORZ ENDOVISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1