BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1372981 · Received April 24, 2009

    Report

    Report Number
    1221826-2009-00012
    Event Type
    Other
    Date Received
    April 24, 2009
    Date of Event
    March 13, 2009
    Report Date
    April 22, 2009
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP REPORTS THAT THEY WERE USING A 4.8 MM CABLE WITH THE 4.0MM ENT TELESCOPE USED DURING PROCEDURE. KARL STORZ LABELING STATES THAT: THE APPROPRIATE SIZE LIGHT CABLE SHOULD BE USED TO MINIMIZE THE HEAT ENERGY GENERATED FROM THE LIGHT SOURCE. USE OF APPROPRIATE SIZE LIGHT CABLE WILL REDUCE THE RISK OF PT BURNS, AS WELL AS THE RISK OF IGNITING FLAMMABLE MATERIAL. TELESCOPE DIAMETER - LIGHT CABLE; 4.0 MM AND LESS - 2.5 MM CABLE; 4.0 MM TO 6.0 MM - 3.5 MM CABLE; LARGER THAN 6.0 MM - 4.8 MM CABLE. WE BELIEVE THE MOST LIKELY CAUSE OF THE OVERHEATING OF THE SCOPE WAS USAGE OF THE INCORRECT CABLE.

    Description of Event or Problem · 1

    HOSPITAL REPORTS THAT DURING AN ENT PROCEDURE, IT WAS ALLEGED THAT PT REC'D MINOR BURN TO NASAL PASSAGE FROM TIP OF INSTRUMENT. NO MEDICAL ATTENTION WAS NECESSARY, AND PT'S CONDITION AFTER PROCEDURE COMPLETED WAS GOOD. NO PT PROBLEMS REPORTED SINCE DATE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ LIGHT SOURCE FFS KARL STORZ ENDOVISION 201331-20-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other