BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ

    MDR report key: 3081056 · Received March 29, 2013

    Report

    Report Number
    2020550-2013-00012
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 29, 2013
    Manufacturer
    KARL STORZ ENDOVISION
    Product Code
    FFS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, DURING AN ENT PROCEDURE, THE DOCTOR FELT THE SCOPE GET HOT; HE FOUND THAT HE WAS USING AN INCORRECT LIGHT CABLE FOR THE SCOPE IT WAS ATTACHED TO. WHEN DOCTOR SWITCHED TO A SMALLER DIAMETER LIGHT CABLE HE NOTED THAT PT HAD RECEIVED A MINOR BURN ON THE OUTSIDE OF THE NOSE. THE SCOPE AND LIGHT CABLE CONNECTION MOST LIKELY MADE CONTACT WITH PATIENT. BURN WAS TREATED WITH SALVE AND PROCEDURE COMPLETED. PT CONDITION IS GOOD. PLEASE REFERENCE MFR # 1221826-2013-00012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130564 KARL STORZ LIGHT CABLE FFS KARL STORZ ENDOVISION 495NA RZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other