BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 860 SEAT CFK STAINLESS

    MDR report key: 21845139 · Received April 15, 2025

    Report

    Report Number
    0008010153-2025-00001
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 15, 2025
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED "DULY SURG CTR LOMBARD - THAT THE BEAR HUGGER WAS CAUGHT UNDER THE TABLE AND IT CRASHED DOWN. THEY WOULD LIKE THE FST TO CHECK THE CONDITION OF THE TABLE." A STRYKER FIELD SERVICE TECHNICIAN WAS SENT OUT ON (B)(6) 2025 TO INVESTIGATE FURTHER, IT WAS FOUND THAT THE "TABLE LEG SECTION WOULD NOT MOVE COMPLETELY DOWN" THE TECHNICIAN "REPLACED THE LEG SECTION THAT WAS MISSING A MAGNET FOR THE HALL SENSOR.", AFTER REPAIRS WERE COMPLETED, IT WAS FOUND "TABLE LEG SECTION IS OPERATING NORMALLY". WHILE THE ISSUE WAS PRESENTED IN THE FORM OF THE LEG SECTION NOT OPERATING PROPERLY, THE COMPLAINT ISSUED DESCRIBED USER ERROR BY PLACING A BEAR HUGGER ON THE BASE OF THE TABLE. WITHIN THE OPERATOR MANUAL SURGICAL MOBILE OPERATING TABLE MODELS D 860, D 850, D 830, D 820, D770, D 760 (57445) THERE IS A CLEAR STATEMENT THAT "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." THERE IS ALSO A CLEAR WARNING ON THE PHYSICAL BASE OF THE TABLE TO REMIND THE USER NOT TO PLACE OBJECTS ON THE BASE. A REVIEW OF THE DEVICE HISTORY WAS COMPLETED. ACCORDING TO THE MANUFACTURING DHR, THE TABLE WAS MANUFACTURED ON 18 DEC 2019 AND MET QUALITY SPECIFICATIONS PRIOR TO SHIPMENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE AND THERE WAS PATIENT IMPACT/INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS FAILURE MODE HAS NOT EXCEEDED ANY THRESHOLD AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BEAR HUGGER WAS CAUGHT UNDER THE TABLE AND IT CRASHED DOWN. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350838 OPERON D 860 SEAT CFK STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown