BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM

    MDR report key: 17703269 · Received September 7, 2023

    Report

    Report Number
    9610617-2023-00249
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    April 29, 2022
    Report Date
    September 29, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OAY
    UDI-DI
    04048551290705
    PMA / PMN Number
    P050027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS TO CORRECT THE PRODUICT CODE FROM FCW TO THE CORRECT PRODUCT CODE OF OAY. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: 968350.

    Additional Manufacturer Narrative · 0

    THE PREVIOUS REPORTABILITY DECISION FOR THIS EVENT WAS REVERSED BASED ON A RETROSPECTIVE REVIEW. THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LIGHT WAS SWITCHED ON WITHOUT THE OTHER END OF THE CORD BEING PLUGGED INTO THE SCOPE. THIS RESULTED IN A SMALL HOLE IN THE DRAPE NEAR THE PATIENT'S LOWER EXTREMITIES. THE PATIENT WAS ASSESSED, AND NO HARM HAD REACHED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101813 FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM OAY KARL STORZ SE & CO. KG 495NAC 04048551290705

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown