BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, CONNECTED OR HUB BASE SYSTEM

    MDR report key: 17007928 · Received May 25, 2023

    Report

    Report Number
    0002936485-2023-00536
    Event Type
    Malfunction
    Date Received
    May 25, 2023
    Date of Event
    May 4, 2023
    Report Date
    May 7, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OUG
    UDI-DI
    07613327413281
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: LOSS OF IMAGE. PROBABLE ROOT CAUSE: ¿ CABLES, CONNECTORS, SOURCES, OR SINKS ¿ CAPTURE CARD, MOTHERBOARD, POWER SUPPLY ¿ SDC FIRMWARE ¿ OVER-HEATING ¿ SDC APPLICATION SOFTWARE [COR, IP], CLARITY PACKAGE ¿ CLARITY ALGORITHM ¿ MANUFACTURING DEFECTS ¿ USE ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541563 PKG, CONNECTED OR HUB BASE SYSTEM MEDICAL DEVICE DATA SYSTEM OUG STRYKER ENDOSCOPY-SAN JOSE 07613327413281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown