BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 2990051 · Received February 21, 2013

    Report

    Report Number
    9610617-2013-00006
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 20, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    EQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL PROVIDED A PICTURE SHOWING THAT THE PIN THAT ATTACHES LIGHT CARRIER TO LARYNGOSCOPE WAS BROKEN OFF; THE LIGHT CARRIER WOULD STILL WORK, BUT IT WOULD NOT BE COMPLETELY FIXED TO THE SIDE OF THE LARYNGOSCOPE WHICH RESULTED IN THE LIGHT CARRIER AND LIGHT CABLE CONNECTION TOUCHING THE PT'S FACE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR PERFORMED A LARYNGOSCOPIC REMOVAL OF VOCAL POLYP; WHEN THEY REMOVED TOWELING DRAPED AROUND PT'S FACE THEY NOTICED TIP OF NOSE WAS VERY WHITE; THE DOCTOR CHARACTERIZED THIS AS A MINOR BURN. THEY EXAMINED THE LIGHT CARRIER AND FOUND THAT AN ATTACHMENT PIN TO SECURE THE LIGHT CARRIER WAS BROKEN OFF; THEY THINK THIS CAUSED LIGHT CARRIER/LIGHT CABLE TO MOVE AND MAKE CONTACT WITH PT'S NOSE. PT IS HEALING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75117 KARL STORZ FIBER OPTIC LIGHT CARRIER EQH KARL STORZ GMBH & CO. KG 8580BL OY

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other