BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHEATH, LONG, FOR WA22018A AND WA22019A

    MDR report key: 16935107 · Received May 15, 2023

    Report

    Report Number
    9610773-2023-01323
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Report Date
    July 6, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HIH
    UDI-DI
    04042761051514
    PMA / PMN Number
    K931994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION AND CORRECTION. 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, THE ROOT CAUSE OF THE OPTICAL ISSUE WAS IMPROPER HANDLING BY THE USER. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K931995.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT AN INNER SHEATH HAD OPTICAL VISION ISSUES. THE VISION WAS TRUNCATED WHEN THE OPTIC WAS INSERTED IN THE INTERNAL SHEATH (CERAMIC OF THE VISIBLE SHEATH). THE DEVICE WAS SENT IN FOR EVALUATION AND REPAIR. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351030 INNER SHEATH, LONG, FOR WA22018A AND WA22019A SURG, NON-EN HIH OLYMPUS WINTER & IBE GMBH WA22017A 20X02 04042761051514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown