BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 0°, AUTOCLAVABLE

    MDR report key: 21120955 · Received January 9, 2025

    Report

    Report Number
    9610773-2025-00318
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    September 16, 2024
    Report Date
    May 30, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075008
    PMA / PMN Number
    K190744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00027. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00027-01. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE CORRECTION, ADDITIONAL INFORMATION FROM THE CUSTOMER AND THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. 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 THAT WAS INITIALLY REPORTED, 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 AND OTHER FINDINGS WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. THE INSPECTION IDENTIFIED BENT OUTER TUBE. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE LIKELY CAUSE OF BENT OUTER TUBE FOUND DURING EVALUATION WAS DUE TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE RIGID VIDEOSCOPE HAD A BENT SHAFT. THIS RESULTED IN DELAY OF THE PROCEDURE FOR MORE THAN 30 MINUTES WHILE THE PATIENT WAS UNDER SEDATION. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT THERE WAS NO PROCEDURAL DELAY. THE PATIENT WAS REFERRED TO ANOTHER FACILITY FOR THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472350 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 0°, AUTOCLAVABLE RIGID VIDEO LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50050A 04042761075008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown