BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERON D 860 SEAT, CFK, STAINLESS

    MDR report key: 18440129 · Received January 3, 2024

    Report

    Report Number
    0008010153-2024-00001
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 7, 2023
    Report Date
    March 22, 2024
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170160
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    ON 7 DEC 2023, IT WAS E-MAILED IN STATING TABLE (A11934) MOVED UNEXPECTEDLY, NEEDS TECH TO INVESTIGATE. THEY WERE PUTTING THE TABLE IN REVERSE MODE AND WHEN THEY MOVED IT, THE TABLE JERKED. THE DOCTOR HAD BEEN HOLDING A CAMERA UNDER THE KIDNEY WHEN IT HAPPENED AND IT PIERCED THE KIDNEY. A STRYKER FIELD SERVICE ENGINEER WAS DISPATCHED TO INVESTIGATE AND RESPONDED ON 7 DEC 2023. DURING THIS INVESTIGATION, IT WAS FOUND THAT THE HAND PENDANT WAS INTERMITTENT, BUT THE ISSUE WAS NOT REPLICATED. BASED ON INFORMATION GATHERED FROM THE FIRST FIELD SERVICE INVESTIGATION, THE FIELD SERVICE ENGINEER WAS SENT OUT AGAIN ON 20 DEC 2023. DURING THE SECOND INVESTIGATION, THERE WERE IMAGES TAKEN OF THE UNDERSIDE OF THE LEG SECTION AS WELL AS ANOTHER 10 CYCLES OF TESTING. THE SECOND INVESTIGATION WAS PERFORMED TO DETERMINE IF THE ISSUE COULD NOT BE REPLICATED AS WELL AS TO SEE IF A POTENTIAL CAUSE OF THE ISSUE WOULD BE OBJECTS PLACED UNDERNEATH THE TABLE. BASED ON THE INFORMATION THAT WAS GATHERED FROM THE FIELD SERVICE ENGINEER, A POTENTIAL ROOT CAUSE OF THIS ISSUE IS THE PLACEMENT OF OBJECTS UNDERNEATH THE TABLE. THIS CAN BE SEEN WITHIN SOME OF THE DAMAGE TO THE UNDERSIDE OF THE LEG SECTION OF THE TABLE. THIS ISSUE COULD NOT BE REPLICATED AND THEREFORE IT CANNOT BE CONFIRMED THAT THE ISSUE WAS CAUSED BY PLACING OBJECTS ON THE UNDERNEATH BASE OF THE TABLE. THIS ISSUE WAS DISCOVERED DURING A MEDICAL PROCEDURE, AND THERE WAS PATIENT IMPACT AND AN ADVERSE EVENT REPORTED. THIS FAILURE MODE HAS NOT EXCEEDED ANY THRESHOLD AND WILL CONTINUE TO BE MONITORED PER DWI2003. IF FURTHER INFORMATION IS OBTAINED A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TABLE MOVED UNEXPECTEDLY. THEY WERE PUTTING THE TABLE IN REVERSE MODE AND WHEN THEY MOVED IT, THE TABLE JERKED. THE DOCTOR HAD BEEN HOLDING A CAMERA UNDER THE KIDNEY WHEN IT HAPPENED AND IT PIERCED THE KIDNEY WHICH REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TABLE MOVED UNEXPECTEDLY. THEY WERE PUTTING THE TABLE IN REVERSE MODE AND WHEN THEY MOVED IT, THE TABLE JERKED. THE DOCTOR HAD BEEN HOLDING A CAMERA UNDER THE KIDNEY WHEN IT HAPPENED AND IT PIERCED THE KIDNEY WHICH REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505985 OPERON D 860 SEAT, CFK, STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG 07613327170160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other