BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARCO INC

    MDR report key: 17885885 · Received October 6, 2023

    Report

    Report Number
    3004578804-2023-00001
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    August 8, 2023
    Report Date
    October 6, 2023
    Manufacturer
    BARCO INC
    Product Code
    FWB
    UDI-DI
    00700621719533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED ADDITIONAL INFORMATION FROM OUR CUSTOMER, WHO INTEGRATES THE BARCO DEVICE INTO THEIR SYSTEM IN THE OPERATING ROOM, THAT IT WAS NOT THE BARCO DEVICE THAT MALFUNCTIONED, BUT ONE OF THE OTHER COMPONENTS IN THE SYSTEM, CAUSING THE IMAGE LOSS ON THE SURGICAL DISPLAY.

    Additional Manufacturer Narrative · 0

    THE INITIAL INFORMATION FROM THE REPORT IS NOT SUFFICIENT TO DETERMINE WHETHER THE IMAGE LOSS WAS CAUSED BY MALFUNCTION OF THE DISPLAY OR IF THERE HAS BEEN ANOTHER CAUSE, E.G. MALFUNCTION OF ANOTHER DEVICE IN THE VIDEO CHAIN.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: "PATIENT PRESENTED FOR ROBOTIC-ASSISTED LAPAROSCOPIC DISTAL PANCREATECTOMY AND SPLENECTOMY. DURING INSERTION OF THE INITIAL TROCAR USING THE CAMERA TO VISUALIZE ENTRY, THE STRYKER MONITOR SCREEN WENT BLANK AND VISUALIZATION WAS LOST. SURGEON HALTED ENTRY, BUT WHEN SCREEN IMAGE RETURNED A MOMENT LATER, THE TROCAR WAS NOTED TO HAVE PERFORATED THE COLON. THE CASE WAS CONVERTED TO OPEN TO FACILITATE REPAIR OF 0.5CM LENGTH TRANSVERSE COLOTOMY. THE SURGERY PROGRESSED AS PLANNED WITH NO FURTHER COMPLICATIONS. LOSS OF VISUALIZATION MAY HAVE CONTRIBUTED TO PATIENT INJURY." ADVERSE CONSEQUENCES DETAILS:THE TROCAR WAS NOTED TO HAVE PERFORATED THE COLON. THE CASE WAS CONVERTED TO OPEN TO FACILITATE REPAIR OF 0.5CM LENGTH TRANSVERSE COLOTOMY. THE SURGERY PROGRESSED AS PLANNED WITH NO FURTHER COMPLICATIONS. LOSS OF VISUALIZATION MAY HAVE CONTRIBUTED TO PATIENT INJURY THIS EVENT HAS BEEN REPORTED BY THE FACILITY UNDER MDR REPORT KEY 17756306, REPORT NUMBER MW5145684.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: "PATIENT PRESENTED FOR ROBOTIC-ASSISTED LAPAROSCOPIC DISTAL PANCREATECTOMY AND SPLENECTOMY. DURING INSERTION OF THE INITIAL TROCAR USING THE CAMERA TO VISUALIZE ENTRY, THE STRYKER MONITOR SCREEN WENT BLANK AND VISUALIZATION WAS LOST. SURGEON HALTED ENTRY, BUT WHEN SCREEN IMAGE RETURNED A MOMENT LATER, THE TROCAR WAS NOTED TO HAVE PERFORATED THE COLON. THE CASE WAS CONVERTED TO OPEN TO FACILITATE REPAIR OF 0.5CM LENGTH TRANSVERSE COLOTOMY. THE SURGERY PROGRESSED AS PLANNED WITH NO FURTHER COMPLICATIONS. LOSS OF VISUALIZATION MAY HAVE CONTRIBUTED TO PATIENT INJURY." ADVERSE CONSEQUENCES DETAILS:THE TROCAR WAS NOTED TO HAVE PERFORATED THE COLON. THE CASE WAS CONVERTED TO OPEN TO FACILITATE REPAIR OF 0.5CM LENGTH TRANSVERSE COLOTOMY. THE SURGERY PROGRESSED AS PLANNED WITH NO FURTHER COMPLICATIONS. LOSS OF VISUALIZATION MAY HAVE CONTRIBUTED TO PATIENT INJURY. THIS EVENT HAS BEEN REPORTED BY THE FACILITY UNDER MDR REPORT KEY 17756306, REPORT NUMBER MW5145684.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307714 BARCO INC 0240-031-050 FWB BARCO INC 0240-031-050 00700621719533

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention