BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE

    MDR report key: 16873400 · Received May 4, 2023

    Report

    Report Number
    9610773-2023-01220
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    March 16, 2023
    Report Date
    May 4, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074971
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PMA/510(K): K190744. THE DEVICE WAS NOT RETURNED TO OLYMPUS. DURING THEIR INVESTIGATION, THE SBC WAS NOT ABLE TO CONFIRM THE REPORTED ISSUE. THE CUSTOMER REPORTED, THAT THE ENTIRE IMAGE WAS GREEN. THE REPORTED ENDOEYE WAS NOT RETURNED TO THE CORRESPONDING REPAIR CENTER. THEREFORE, A DETAILED INSPECTION OF THE ENDOEYE WAS NOT POSSIBLE. A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OLYMPUS, ON MAR 17TH, DURING LAPAROSCOPIC SURGERY. IT WAS FOUND THAT THE ENTIRE IMAGE WAS GREEN. THEN CHANGED TO ANOTHER ONE AND FINISHED THE PROCEDURE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538146 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE RIGID VIDEO SCOPE HET OLYMPUS WINTER & IBE GMBH WA50042A 04042761074971

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown