BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG, CONNECTED OR HUB BASE SYSTEM

    MDR report key: 17409801 · Received July 27, 2023

    Report

    Report Number
    0002936485-2023-00734
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 19, 2024
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    07613327413281
    PMA / PMN Number
    K222079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. ALLEGED FAILURE: SHUT DOWN DURING A CASE. PROBABLE ROOT CAUSE: CABLES, CONNECTORS, SOURCES, OR SINKS, CAPTURE CARD, MOTHERBOARD, POWER SUPPLY, SDC FIRMWARE, OVER-HEATING (AIR DUCT, FANS, HEAT SINKS, DUST, VENTS), SDC APPLICATION SOFTWARE, CLARITY PACKAGE, CLARITY ALGORITHM, USE ERROR , CYBERSECURITY - ASSETS - VIDEO INPUT/OUTPUT, VIDEO ROUTING, TELECONFERENCING/CALLS/VIDEO STREAMING. 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.

    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
    662262 PKG, CONNECTED OR HUB BASE SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 07613327413281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown