BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 860 SEAT, CFK, STAINLESS

    MDR report key: 12909411 · Received December 1, 2021

    Report

    Report Number
    0008010153-2021-00008
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 2, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED "THE D860 TABLE (S/N: (B)(4)) WAS IN USE DURING A CASE AND WAS LOWERED ON TOP OF THE PATIENT WARMER THAT WAS UNDER THE TABLE, LIFTING IT UP OFF THE FLOOR AT THE HEAD END. THAT WAS REALIZED AND IMMEDIATELY REMEDIED. LATER ON DURING THE SAME CASE, THE BED SUDDENLY JERKED AND FELL DOWNWARD. IT THEN JERKED DOWN AGAIN, AND THEN AGAIN. THE BED FELL 3 TIMES UNTIL IT WAS IN ITS LOWEST POSITION. THE PATIENT WAS STRAPPED TO THE BED AND WAS NOT INJURED; HOWEVER, IT WAS AFTER INCISION." (B)(4) WAS OPENED ON (B)(6) 2021. A STRYKER FIELD SERVICE TECHNICIAN WAS DISPATCHED AND RESPONDED TO THE COMPLAINT ON 3 NOV 2021 AND PROVIDED THE FOLLOWING REPORT: "AFTER ACCESSING THE TABLE I DID A VISUAL INSPECTION AND DID NOT FIND ANY DAMAGE TO THE OUTSIDE OF THE TABLE. I TESTED ALL FUNCTIONS WITH THE HAND PENDANT AND CYCLE TESTED THE TABLE WITH THE SOFTWARE WITH NO ERRORS OR ISSUES. I THEN OPENED UP THE BASE TO CHECK FOR ANY DAMAGE AND ONCE AGAIN EVERYTHING LOOKED GOOD." THE ROOT CAUSE FOR THIS FAILURE MODE, AND CONFIRMED BY THE CUSTOMER, IS CUSTOMER MISUSE. THE CUSTOMER REPORTED THAT THE TABLE WAS LOWERED ONTO A DEVICE THAT WAS BEING STORED ON OR NEAR THE BASE OF THE TABLE, WHICH IS NOT ALLOWED. THE TABLE COLLIDED WITH THE DEVICE WHICH CAUSED THE TABLE CENTER LIFT COLUMN TO JAM. AFTER THE DEVICE WAS DISLODGED FROM THE TABLE BASE BY THE CUSTOMER THE SURGICAL PROCEDURE RESUMED WITHOUT PROPERLY CHECKING ALL FUNCTIONS OF THE TABLE PRIOR TO USE. LATER, DURING SURGERY THE TABLE UNJAMMED AND LOWERED TO ITS HYDRAULIC LIMIT. THE PATIENT WAS SECURED AT ALL TIMES AND THERE WAS NO REPORT OF PATIENT OR USER INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS UNINTENDED MOVEMENT OF THE TABLE AFTER BEING LOWERED ON AN EXTERNAL PIECE OF EQUIPMENT. THERE WERE NO REPORTED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807780 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