BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N.A.

    MDR report key: 14353358 · Received May 11, 2022

    Report

    Report Number
    14353358
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 29, 2022
    Report Date
    May 2, 2022
    Manufacturer
    KARL STORZ GMBH CO. KG
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BEFORE PERFORMING THE FINAL TIME OUT, ALL CORDS AND EQUIPMENT WERE SET UP. WHEN TRYING TO PLUG IN THE LIGHT CORD, THE REPRESENTATIVE TRIED TO HELP AND PLUGGED IN THE LIGHT SOURCE IN THE TOWER. HE PRESSED THE LIGHT ON BUTTON WHEN THE OTHER END OF THE LIGHT CORD WAS NOT PLUGGED INTO THE SCOPE. THE SCRUB TECH IMMEDIATELY NOTICED IT AND THE LIGHT SOURCE WAS TURNED OFF. UNFORTUNATELY, THE LIGHT HAD PLACED A SMALL HOLE IN THE DRAPE NEAR-PATIENT LOWER EXTREMITIES. THE PATIENT WAS ASSESSED, AND NO HARM HAD REACHED THE PATIENT OR THE BLANKETS UNDER THE DRAPES. THE PATIENT WAS AGAIN ASSESSED CAREFULLY AT THE END OF THE CASE, AND NO REDNESS, SWELLING, OR ABNORMALITIES WERE FOUND. WHEN THE REP WAS ASKED IF HE HAD PLACED THE ON BUTTON "ON" THE LIGHT, HE STATED THAT HE HAD. MANUFACTURER RESPONSE FOR FIBER OPTIC LIGHT CABLE, KARL STORZ ENDOSCOPY-AMERICA, INC. (PER SITE REPORTER). THE REPRESENTATIVE WAS THERE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789448 N.A. LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW KARL STORZ GMBH CO. KG 495NAC

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA Female