BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERON D 860 SEAT, CFK, STAINLESS

    MDR report key: 7215251 · Received January 24, 2018

    Report

    Report Number
    0008010153-2018-00002
    Event Type
    Injury
    Date Received
    January 24, 2018
    Date of Event
    October 27, 2017
    Report Date
    June 1, 2018
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN AN EFFORT TO RECREATE THE REPORTED EVENT, A SIMULATED USE TEST WAS CONDUCTED USING A OPERON D850 TABLE (S/N (B)(4) LOCATED IN THE FLOWER MOUND FACILITY. THE SIMULATED USE TEST WAS NOT CONDUCTED ON THE ACTUAL TABLE INVOLVED IN THE REPORTED EVENT (S/N (B)(4) AS THE TABLES ARE CONSIDERED EQUIVALENT FOR THE PURPOSES OF THIS TEST. WE WERE ABLE TO SHOW THROUGH THIS TESTING THE EXACT DESCRIPTION (SEE POINTS 1-3) OF THE REPORTED EVENT FROM THE SURGEON¿S PERSPECTIVE BY PLACING A CART UNDERNEATH THE LEG SECTION, MOVING THE TABLE INTO REVERSE TRENDELENBURG AND SUBSEQUENTLY REMOVING THE CART FROM UNDERNEATH THE LEG SECTION (POINTS 1-3 ARE ANNOTATED ON THE ATTACHED VIDEO): POSITIONING TO STEEP REVERSE TREND IN WHICH THE TABLE SEEMED AS THOUGH IT WAS SLIDING TOWARDS THE HEAD 6-12 INCH TABLE DROP WITH AN ASSOCIATED LOUD NOISE HEAD LURCHED FORWARD IN THE DIRECTION OF STEEP REVERSE TRENDENLENBERG THAT WOULD HAVE LAUNCHED THE PATIENT OFF THE TABLE IF SHE WASN'T STRAPPED IN. GIVEN THE FACT THAT THE PATIENT IS HEAVILY DRAPED AND THE SURGERY BEING PERFORMED WAS A LAPAROSCOPIC SLEEVE GASTRECTOMY (LESS LIKELY THAT A MEMBER OF THE SURGICAL TEAM WOULD BE STANDING NEAR FOOT OF THE TABLE TO SEE OR FEEL THAT THERE WAS SOMETHING LODGED UNDERNEATH THE LEG SECTION), THIS TESTING CONFIRMS THAT THE MOST LIKELY CAUSE OF THE SUDDEN TABLE DROP WAS AN OBJECT LODGED UNDERNEATH THE LEG SECTION THAT WAS SUBSEQUENTLY REMOVED (EITHER ON ITS OWN OR BY SOMEONE IN THE ROOM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE TABLE WAS BEING PUT INTO REVERSE TREND, THE TABLE STOPPED MOVING AND FROZE IN PLACE AND THEN ALLEGEDLY, THE TABLE DROPPED ABOUT AN INCH. THE CHANGE IN THE TABLE HEIGHT CAUSED A RETRACTOR TO PENETRATE THE DIAPHRAGM AND GO THROUGH THE RIGHT ATRIUM OF THE PATIENTS' HEART. EMERGENCY OPEN HEART SURGERY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    ¿PREPARED AT REQUEST OF COUNSEL.¿ IT WAS REPORTED THAT WHEN THE TABLE WAS BEING PUT INTO REVERSE TREND, THE TABLE STOPPED MOVING AND FROZE IN PLACE AND THEN ALLEGEDLY, THE TABLE DROPPED ABOUT AN INCH. THE CHANGE IN THE TABLE HEIGHT CAUSED A RETRACTOR TO PENETRATE THE DIAPHRAGM AND GO THROUGH THE RIGHT ATRIUM OF THE PATIENTS' HEART. EMERGENCY OPEN HEART SURGERY WAS PERFORMED. AN INVESTIGATION IS IN PROCESS AND STRYKER WILL FILE A SUPPLEMENTAL AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TABLE WAS BEING PUT INTO REVERSE TREND, THE TABLE STOPPED MOVING AND FROZE IN PLACE AND THEN ALLEGEDLY, THE TABLE DROPPED ABOUT AN INCH. THE CHANGE IN THE TABLE HEIGHT CAUSED A RETRACTOR TO PENETRATE THE DIAPHRAGM AND GO THROUGH THE RIGHT ATRIUM OF THE PATIENTS' HEART. EMERGENCY OPEN HEART SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59108 OPERON D 860 SEAT, CFK, STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention