BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT CORD (SINGLE FIBER OPTIC CABLE, 10 FT).

    MDR report key: 11874573 · Received May 24, 2021

    Report

    Report Number
    MW5101507
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 13, 2021
    Report Date
    May 20, 2021
    Manufacturer
    INVUITY, INC. / STRYKER INSTRUMENTS
    Product Code
    FST
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INVUITY SINGLE FIBER OPTIC CABLE, 10 FT LIGHT CORD BECAME OVERHEATED IN SEVERAL AREAS DUE TO COMPROMISED FIBERS WITHIN THE CORD. THE EXTERIOR OF THE CABLE APPEARED NORMAL, HOWEVER, WHEN CONNECTED TO THE LIGHT BOX THERE WERE VISIBLE BRIGHT SPOTS THAT BECAME OVERHEATED DUE TO COMPROMISE WITHIN THE CORD. THE FIBER OPTIC CABLE WAS CONNECTED TO A RETRACTOR FOR USE DURING SURGERY. OVERHEATED AREAS OF THE CABLE RESULTED IN BURNS TO PATIENT'S CHEST. THE FIBER OPTIC CABLE WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW CORD ONCE THE OVERHEATING AND BURNS WERE NOTED. INVUITY VENDOR WAS NOTIFIED AND INDICATED THE CABLE COULD HAVE BEEN TOO TIGHTLY WOUND, THEREFORE CAUSING CORD FIBERS TO BECOME COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765365 LIGHT CORD (SINGLE FIBER OPTIC CABLE, 10 FT). LIGHT, SURGICAL, FIBEROPTIC FST INVUITY, INC. / STRYKER INSTRUMENTS 19120912

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention