BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 830 SEAT CFK STAINLESS

    MDR report key: 23080083 · Received September 17, 2025

    Report

    Report Number
    0008010153-2025-00007
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170061
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY TANNER MED CTR VILLA RICA-UNCONFIRMED OR (TABLE S/N (B)(6) IT WAS EMAILED IN STATING PUTTING THE TABLE IN REVERSE TREND AND THE TABLE CAME OFF THE GROUND. THEY HAD TO HIT TABLE UP AND IT CAME CRASHING DOWN. THEY WERE DOING A LAP CHOLE AND PATIENT WAS SUPINE IN NORMAL ORIENTATION. PATIENT WAS ONLY 128 LBS. THERE WERE INCISIONS MADE, BUT NO HARM WAS DONE. A STRYKER FIELD SERVICE TECHNICIAN WAS SENT OUT ON 25 AUG 2025, IT WAS DISCOVERED "INSPECTED TABLE FOR PHYSICAL DAMAGE - NONE FOUND. TABLE WORKING NORMALLY. NO ISSUES WITH THE TABLE. TALKED TO STAFF - THE TABLE WAS IN HEAD DOWN POSITION, WHEN THEY LOWERED THE TABLE - THEY FOUND THE LEG EXTENSION WAS ON TOP OF THE MAYO STAND. THIS MADE THE BASE OF THE TABLE RISE.", THERE WERE NO ISSUES FOUND WITH THE TABLE FUNCTIONALITY. IN THE OPERON OPERATOR'S MANUAL IT IS LISTED, "THE EXPECTED LIFE OF THE OPERON® OR TABLES IS 10 YEARS FROM THE DATE OF PRODUCT INSTALLATION.", THIS PRODUCT WAS MANUFACTURED IN 2014 AND COMPLAINT WAS REPORTED IN 2025 MEANING IT IS AN 11 YEAR OLD TABLE. THERE IS ALSO A CLEAR WARNING IN THIS MANUAL LISTING "OBJECTS LYING ON THE BASE COVER CAN END UP AGAINST THE TELESCOPING COLUMN SHIELDS WHEN THE OR TABLE IS BEING REPOSITIONED AND CAUSE DAMAGE TO THE COVERS AND BRACKETS INSIDE THE COVERS. 1. NEVER PLACE OBJECTS ON THE BASE COVER." THE ROOT CAUSE OF THE ISSUE WAS FOUND TO BE THE OBJECTS PLACED NEAR THE BASE OF THE TABLE LEADING TO UNINTENDED MOVEMENT, WHICH CAN BE TRACED TO USER ERROR. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE, AND THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENT REPORTED. THIS FAILURE MODE HAS NOT EXCEEDED ANY THRESHOLD AND WILL CONTINUE TO BE MONITORED.

    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 WHEN PUTTING THE TABLE IN REVERSE TREND AND THE TABLE CAME OFF THE GROUND. THEY HAD TO HIT TABLE UP AND IT CAME CRASHING DOWN. THEY WERE DOING A LAP CHOLE AND PATIENT WAS SUPINE IN NORMAL ORIENTATION. THERE WERE INCISIONS MADE, BUT NO HARM WAS DONE. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PUTTING THE TABLE IN REVERSE TREND AND THE TABLE CAME OFF THE GROUND. THEY HAD TO HIT TABLE UP AND IT CAME CRASHING DOWN. THEY WERE DOING A LAP CHOLE AND PATIENT WAS SUPINE IN NORMAL ORIENTATION. THERE WERE INCISIONS MADE, BUT NO HARM WAS DONE. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597756 OPERON D 830 SEAT CFK STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG 07613327170061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown