BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBER OPTIC LIGHT CABLE

    MDR report key: 17136878 · Received June 15, 2023

    Report

    Report Number
    9610617-2023-00125
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 16, 2023
    Report Date
    November 15, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OAY
    UDI-DI
    04048551168868
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER MANUFACTURE: THE PRODUCT WAS NOT RETURNED. ACCORDING TO THE CUSTOMER, THE OPTIC 7230AA (ZC 200963352 MDR23-124 972991) WITH THE 495NA LIGHT CABLE MENTIONED HERE HEATED UP CONSIDERABLY DURING THE 5-HOUR OPERATION AND THE PATIENT SUFFERED A 1ST DEGREE BURN. THE MENTIONED LIGHT CABLE WAS DISPOSED OF BY THE USER AND IS NOT AVAILABLE FOR A MORE DETAILED INVESTIGATION OF THE INCIDENT OR WILL NOT BE RETURNED. FOR THIS REASON, A MORE DETAILED INVESTIGATION AND ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. A POSSIBLE CAUSE FOR THE STRONG HEATING OF THE OPTICS AND THE 495NA LIGHT CABLE USED IN COMBINATION HERE AND THE RESULTING BURN OF THE PATIENT MAY BE THE USE OF AN OFF-BRAND LIGHT SOURCE, A LIGHT OUTPUT SET TOO HIGH OR CONTAMINATION OF THE LIGHT CONNECTION ON THE OPTICS SIDE. TOO LITTLE DISTANCE TO THE SURROUNDING TISSUE CAN ALSO CAUSE A BURN. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    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: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ON-GOING. PRODUCT HAS BEEN RETURNED FOR EVALUATION BUT HAS NOT BEEN COMPLETED. SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EVENT WITH THE 495NA FIBER OPTIC CABLE. ACCORDING TO THE INFORMATION RECEIVED, WHILE USING THE LIGHT CABLE ON A PATIENT, THE SCOPE ATTACHED TO THE LIGHT CABLE OVERHEATED INJURING THE PATIENT. PATIENT SUFFERED WHAT APPEARED TO BE THERMAL BURN 1ST DEGREE. PER THE FACILITY THE SCOPE AND LIGHT CABLE WERE USED DURING THE ENTIRE SURGICAL PROCEDURE, APPROXIMATELY 5 HOURS. THE PATIENT SUFFERED WHAT APPEARED TO BE A THERMAL BURN 1ST DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1976735 FIBER OPTIC LIGHT CABLE 230CM,03.5 MM OAY KARL STORZ SE & CO. KG 495NA CG 04048551168868
    838281 FIBER OPTIC LIGHT CABLE 230CM,03.5 MM OAY KARL STORZ SE & CO. KG 495NA CG 04048551168868

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Other 7230AA