BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERON D 830 US SEAT, CFK

    MDR report key: 9591778 · Received January 15, 2020

    Report

    Report Number
    0008010153-2020-00001
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 26, 2019
    Report Date
    April 20, 2020
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, IT WAS REPORTED THAT THE OPERON D830 SURGICAL TABLE DROPPED RAPIDLY DURING A CASE. A STRYKER FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO THE ACCOUNT ON 30 DECEMBER 2019 TO INSPECT THE SURGICAL TABLE AND INTERVIEW THE HOSPITAL STAFF. DURING THE STAFF INTERVIEW, THE FST DISCOVERED THAT THE ISSUE OCCURRED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE STAFF STATED THAT DURING THE SURGERY THE TABLE SUDDENLY DROPPED, CAUSING THE GALL BLADDER TO RUPTURE. THE STAFF STATED THAT THE TABLE HEIGHT WAS AT MIDWAY POSITION, AND THE HAND PENDANT TREND FUNCTION WAS BEING USED WHEN THE TREND FUNCTION STALLED ABRUPTLY, THE TABLE BEGAN TO SLIDE, AND THEN TABLE SUDDENLY DROPPED TO ITS LOWEST SETTING. AS THE INTERVIEW CONTINUED, THE HOSPITAL STAFF STATED THAT THE TABLE DID NOT HIT ANYTHING, THAT THERE WERE NO DEVICES NEAR OR UNDER THE TABLE, AND THAT THERE WERE NO UNEXPECTED NOISES HEARD. THE FST THEN BEGAN THE TABLE INSPECTION. IT WAS NOTED THAT THE BATTERIES WERE CHARGED AND THAT THE HAND PENDANT WAS IN NORMAL MODE. THE FST THEN BEGAN FUNCTIONAL TESTING, STARTING WITH THE TABLE AT ITS LOWEST SETTING WITH THE SLIDE MAXED AT HEAD LIMIT. THE FST NOTED DAMAGE TO THE COLUMN SHIELD AS THE SHIELD HAD COME OFF OF ITS GUIDES. THE TORQUE SCREWS ON FOOT SHIELD WERE SHAVED OFF, THE SHIELD COLUMN AT THE HEAD END OF THE TABLE WAS DAMAGED AND BENT DOWNWARD, AND THE TELESCOPIC COVER SHIELD AND BELLOWS COVER WERE SPLIT/MISALIGNED AND DAMAGED . THE PATIENT RIGHT FOOT SECTION RAIL WAS VERY LOOSE (NO ISSUE WITH PATIENT LEFT RAIL). THE PATIENT RIGHT FOOT SECTION DID NOT SIT FLUSH AGAINST MAIN BODY, AS IT WAS FOUND TO BE BENT/DAMAGED DOWNWARD (NO ISSUE WITH PATIENT LEFT). THE PATIENT RIGHT LEG SPAR WAS ALSO LOOSE (NO ISSUE WITH PATIENT LEFT). THE FST THEN CONNECTED TO TABLE AND ENTERED SERVICE SOFTWARE TO DOWNLOAD THE ERROR REPORT. THERE WERE NO ERRORS FOUND, EXCEPT TYPICAL 24V AND POWER STARTUP. THE TABLE TOP SECTIONS WERE REMOVED AND FUNCTIONAL TESTING WAS PERFORMED WITH NO ISSUES FOUND. THE TABLE TOP SECTIONS WERE THEN REATTACHED TABLE SECTIONS AND ANOTHER ROUND OF FUNCTIONAL TESTING WAS COMPLETED. THE TABLE WAS MOVED THROUGH ALL FUNCTIONS WITH NO FUNCTIONAL ISSUES FOUND. THE PATIENT RIGHT LEG SECTION DOES NOT SIT FLUSH AND IS BENT DOWNWARD, BUT THERE WERE NO ISSUES WITH REMOVING AND ATTACHING THE SECTION. THE COLUMN SHIELDS DO NOT SLIDE EASILY DUE TO DAMAGE. THE FOOT PUMP AND MANUAL PENDANT WERE TESTED TO ENSURE ALL EMERGENCY BACKUP FUNCTIONS WERE WORKING. ALL HYDRAULIC FUNCTIONS WERE FOUND TO BE OPERATIONAL AND WORKING PROPERLY. THE COLUMN SHIELD WAS DROPPED AND ALL HOSES AND CABLES WERE INSPECTED FOR DAMAGE, FRAYS, AND LEAKS. THERE WERE NO ISSUES FOUND. THE HYDRAULIC FLUID LEVELS WERE FULL, AND NO LEAKS WERE PRESENT. PHOTOS OF THE DAMAGE WERE ATTACHED TO THE CASE. THE MANUFACTURING DHR FOR THE DEVICE WAS REVIEWED. THE RECORD SHOWS THAT THE SURGICAL TABLE PASSED ALL FINAL TESTING AND QC CHECKS ON 17 NOVEMBER 2017. THE INSTALLATION AND SERVICE HISTORY FOR THE SURGICAL TABLE WAS REVIEWED. THE TABLE WAS SHIPPED AND INSTALLED IN NOVEMBER 2019, AND THERE WERE NO PRIOR SERVICE TICKETS FOUND FOR THIS DEVICE. ALTHOUGH THE EXACT ROOT CAUSE FOR THIS ISSUE IS UNKNOWN, BASED ON THE PHYSICAL DAMAGE FOUND DURING THE TABLE INSPECTION, POTENTIAL ROOT CAUSES WOULD INCLUDE COLLISION OF THE SURGICAL TABLE WITH A CART OR OTHER EQUIPMENT IN THE ROOM, CAUSING THE UNINTENDED MOVEMENT TO OCCUR. THE OPERON OPERATOR MANUAL (PART #57426, REVISION L), PAGE 75 DISCUSSES THE WARNINGS AND DANGEROUS SITUATIONS THAT CAN OCCUR IF THE TABLE IS USED INCORRECTLY. PARAGRAPH 14 SAYS "NEVER LET THE DEVICE, MOUNTED ACCESSORIES, OR OTHER ADDITIONAL ACCESSORIES COME INTO CONTACT WITH STATIONARY FURNITURE, WALLS, DOOR FRAMES, OTHER DEVICES OR PEOPLE (FOR ASSEMBLED ACCESSORIES AND USE OF MODULES, PAY ATTENTION TO THE MODIFIED TABLE GEOMETRY). DUE TO THE COVID-19 OUTBREAK AND ASSOCIATED TRAVEL RESTRICTIONS, ANY FURTHER TESTING AND EVALUATION OF THE SURGICAL TABLE BY THE STRYKER SURGICAL TABLES ENGINEER HAS BEEN PLACED ON INDEFINITE HOLD. THIS CASE WILL BE REOPENED ONCE FURTHER TESTING AND EVALUATION CAN BE COMPLETED, OR IF NEW INFORMATION BECOMES AVAILABLE. THIS FAILURE MODE HAS NOT EXCEEDED ANY THRESHOLD AND WILL CONTINUE TO BE MONITORED THROUGH STRYKER COMMUNICATIONS NCMB MEETING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING A PROCEDURE YESTERDAY THE TABLE DROPPED QUICKLY FROM A MID-HEIGHT TO IT'S LOWEST HEIGHT. IT HAS BEEN REPORTED THAT THE PATIENT WAS OPEN AND THERE WERE INSTRUMENTS IN THE BELLY AT THE TIME OF THE EVENT. IT WAS REPORTED TO THE COMPLAINANT THAT THE GALL BLADDER RUPTURED AS A RESULT. NO FURTHER INFORMATION IS KNOWN AT THIS TIME."

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT "DURING A PROCEDURE YESTERDAY THE TABLE DROPPED QUICKLY FROM A MID-HEIGHT TO IT'S LOWEST HEIGHT. IT HAS BEEN REPORTED THAT THE PATIENT WAS OPEN AND THERE WERE INSTRUMENTS IN THE BELLY AT THE TIME OF THE EVENT. IT WAS REPORTED TO THE COMPLAINANT THAT THE GALL BLADDER RUPTURED AS A RESULT. NO FURTHER INFORMATION IS KNOWN AT THIS TIME." 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 "DURING A PROCEDURE YESTERDAY THE TABLE DROPPED QUICKLY FROM A MID-HEIGHT TO IT'S LOWEST HEIGHT. IT HAS BEEN REPORTED THAT THE PATIENT WAS OPEN AND THERE WERE INSTRUMENTS IN THE BELLY AT THE TIME OF THE EVENT. IT WAS REPORTED TO THE COMPLAINANT THAT THE GALL BLADDER RUPTURED AS A RESULT. NO FURTHER INFORMATION IS KNOWN AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55713 OPERON D 830 US SEAT, CFK TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG OT 8302075 07613327170092

    Patients

    Seq Age Sex Outcome Treatment
    1