BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERATING TABLE TRUSYSTEM 7000 U (DV)

    MDR report key: 16785964 · Received April 21, 2023

    Report

    Report Number
    3007143268-2023-00010
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    January 19, 2022
    Report Date
    July 25, 2023
    Manufacturer
    BAXTER MEDICAL SYSTEMS GMBH + CO. KG
    Product Code
    GDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED THAT THEY COULD NOT IDENTIFY WHICH OF THE 4 DEVICES WERE INVOLVED. A COMPLAINT WAS NOT INITIATED BY THE CUSTOMER WHEN THE EVENT OCCURRED AND CONTINUED TO USE THE DEVICES WITHOUT ISSUE FOLLOWING THE EVENT. AT THIS TIME THE CUSTOMER IS UNABLE TO PROVIDE HILLROM WITH ACCESS TO THE 4 TABLES FOR FURTHER INVESTIGATION THEREFORE THE ROOT CAUSE CANNOT BE IDENTIFIED. BASED ON THIS NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    FURTHER DETAILS SURROUNDING THE SEQUENCE OF EVENTS AND PRODUCT FAILURE ARE UNKNOWN. HILLROM IS CONTINUING TO ATTEMPT COLLECTION OF THE ADDITIONAL DETAILS REGARDING THE REPORTED PATIENT INJURY AND PRODUCT FAILURE. AT THIS TIME, HILLROM CAN NOT EXCLUDE A PRODUCT MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE SERIOUS INJURY. THEREFORE, HILLROM IS REPORTING THIS EVENT. THE INVESTIGATION IS ONGOING AND FURTHER INFORMATION RECEIVED WILL BE PROVIDED IN A FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT EXPERIENCED SURGICAL COMPLICATIONS WHILE UNDERGOING A ROBOTIC SLEEVE GASTRECTOMY. IT WAS ADDITIONALLY ALLEGED THAT THE PATIENT EXPERIENCED A DELAY OF CARE DUE TO THE SURGICAL TEAM¿S INABILITY TO REPOSITION THE TRUMPF MEDICAL TRUSYSTEM 7000 DV SURGICAL TABLE WHILE PAIRED WITH AN INTUITIVE SURGICAL ROBOT (DAVINCI XI). THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 A PATIENT EXPERIENCED SURGICAL COMPLICATIONS WHILE UNDERGOING A ROBOTIC SLEEVE GASTRECTOMY. IT WAS ADDITIONALLY ALLEGED THAT THE PATIENT EXPERIENCED A DELAY OF CARE DUE TO THE SURGICAL TEAM¿S INABILITY TO REPOSITION THE TRUMPF MEDICAL TRUSYSTEM 7000 DV SURGICAL TABLE WHILE PAIRED WITH AN INTUITIVE SURGICAL ROBOT (DAVINCI XI). THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446281 OPERATING TABLE TRUSYSTEM 7000 U (DV) TABLE, OPERATING-ROOM, ELECTRICAL GDC BAXTER MEDICAL SYSTEMS GMBH + CO. KG 1723633

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability