BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGTAL LIGHT SOURCE CABLE

    MDR report key: 21274108 · Received January 30, 2025

    Report

    Report Number
    3002808148-2025-01589
    Event Type
    Injury
    Date Received
    January 30, 2025
    Date of Event
    December 3, 2024
    Report Date
    May 6, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170304972
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00050-01 THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE COMPLAINT INVESTIGATION. UPDATED FIELDS: B5, H2 AND H6. CORRECTIONS TO B1, B2, AND H1. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, UPON FURTHER FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT SUFFER ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE, THUS CORRECTING B1, B2, AND H1. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED. THE H6 MEDICAL DEVICE PROBLEM REPORTED WOULD NOT BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS NOT RETURNED TO OLYMPUS. THE CUSTOMER'S COMPLAINT WAS CONFIRMED BASED ON THE REMOTE SERVICE INSPECTION CONDUCTED BY THE TECHNICAL ASSISTANCE CENTER (TAC), HOWEVER, A CONCLUSIVE FINDING CANNOT BE CONFIRMED. BASED ON THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES. THIS REPORT IS RELATED TO 071916. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00050. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THE PROCEDURE WAS POSTPONED 35 MINUTES, PRIOR TO THE PATIENT BEING SEDATED. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY UNDER SEDATION, THE DIGITAL LIGHT SOURCE CABLE IN USE WITH A VIDEO PROCESSOR EXPERIENCED A B30 ERROR. THIS RESULTED IN A PROCEDURAL DELAY OF GREATER THAN 30 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582866 DIGTAL LIGHT SOURCE CABLE DIGITAL LIGHT SOURCE CABLE FDF SHIRAKAWA OLYMPUS CO., LTD. MAJ-1933 04953170304972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLV-190