BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 30°, 4 MM

    MDR report key: 15982847 · Received December 14, 2022

    Report

    Report Number
    9610773-2022-00653
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 11, 2022
    Report Date
    May 30, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761020855
    PMA / PMN Number
    K897003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. IT WAS NOTED THAT THE OUTER TUBE WAS BENT AND THE LIGHT GUIDE POST WAS DAMAGED. THE DISTAL FIBER WAS BROKEN AND THE LENS IN THE OPTICAL SYSTEM WAS CHIPPED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE DAMAGED LIGHT POST OCCURRED DUE TO THE USE OF EXCESSIVE FORCE BY THE CUSTOMER. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE TELESCOPE, 30 DEGREE, 4 MM HAD A BENT LIGHT POST THAT WOULD NOT SCREW ON. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446973 TELESCOPE, 30°, 4 MM RIGID ENDOSCOPE TELESCOPE HIH OLYMPUS WINTER & IBE GMBH A22002A 412965 04042761020855

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown