BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 860 SEAT, CFK, STAINLESS

    MDR report key: 16433394 · Received February 23, 2023

    Report

    Report Number
    0008010153-2023-00009
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170160
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2023 AN OPERON SURGICAL TABLE WITH SERIAL NUMBER (B)(4) HAD EXCESSIVE MOVEMENT. THE CUSTOMER STATES: ¿THE PATIENT WAS ON THE TABLE AND THE DOCTOR NOTICED THAT THERE WAS EXCESSIVE MOVEMENT IN THE TABLETOP. THE MOVEMENT WAS IN RELATION TO TREND AND REVERSE TREND MOVEMENT. THE PATIENT WAS OPEN THERE WAS ORGAN EXPOSURE.¿ IT WAS FURTHER REPORTED: THE PROCEDURE BEING PERFORMED WAS A CRANIOTOMY. THE PROCEDURE CONTINUED WITHOUT DELAY AND WITHOUT FURTHER INCIDENT. THE PATIENT WAS NOT HARMED IN ANY WAY AND THERE WAS NO DELAY IN SURGERY. A STRYKER FIELD SERVICE TECHNICIAN WAS DISPATCHED TO INVESTIGATE THE ALLEGED INCIDENT AND CONFIRMED THE TABLE SERIAL NUMBER. THE FST REPORTED: "ARRIVED ON SITE PT ON TABLE SLIP (SLID) ALL THE WAY TO THE HEAD WITH AN ATTACHMENT ON THE TABLE TO SUPPORT HEAD. THE ISSUE WAS THAT THE TABLE WAS BOUNCING ( IT WAS BALANCED OVER THE PIVOT POINT OF THE TABLETOP ALLOWING THE HEAD AND FOOT TO GO UP AND DOWN APPROXIMATELY 1/4 INCH DEPENDING ON IF PRESSURE WAS BEING PLACED ON THE PT (PATIENT'S) HEAD OR FOOT). ONCE THE CASE WAS FINISHED I WAS ABLE TO INSPECT THE TABLE WHEN LOOKING AT THE TREND CYLINDER THE CAPTURE NUT THAT HOLDS THE I BOLT INTO THE TREND CYLINDER SHAFT WAS FINGER TIGHT AND WHEN IT WAS A LITTLE LOSE THE BOLT WAS ABLE TO MOVE BACK AND FORTH DUE TO THE PLAY IN THE COURSE THREADS. AFTER THIS NUT WAS TIGHT THERE STILL FELT TO BE SOME PLAY IN THE TREND CYLINDER. OPENED THE TABLE BASE AND ALSO NOTICED HYDRAULIC FLUID UNDER THE MAIN LIFTING CYLINDER." A COPY OF THE DHR WAS REVIEWED AND THE TABLE PASSED ALL QUALITY INSPECTIONS PRIOR TO SHIPPING. THE SURGICAL TABLE WILL BE RETURNED TO FLOWER MOUND AS A DEPOT REPAIR WHERE IT WILL UNDERGO A COMPLETE ANALYSIS AND ALL FUNCTIONALITIES WILL BE TESTED, REPAIRS WILL BE MADE ACCORDINGLY. A LOANER TABLE WILL BE SENT TO THE CUSTOMER UNTIL THEIR TABLE IS REPAIRED AND RETURNED TO THE ACCOUNT. THE FAILURE MODE HAS NOT BEEN DETERMINED YET HOWEVER THE MOST PROBABLE ROOT CAUSE FOR THIS FAILURE MODE WOULD BE IMPROPER MAINTENANCE. THERE WAS REPORTED PATIENT INVOLVEMENT BUT THERE WAS NO REPORT OF PATIENT INJURY, DELAY IN SURGERY, OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS UNINTENDED MOVEMENT OF THE TABLE. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947884 OPERON D 860 SEAT, CFK, STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG OT 8602065 07613327170160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown