BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D 860 - CFK - POLYMER

    MDR report key: 9868276 · Received March 23, 2020

    Report

    Report Number
    0008010153-2020-00003
    Event Type
    Injury
    Date Received
    March 23, 2020
    Date of Event
    August 31, 2017
    Report Date
    June 19, 2020
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS FIRST REPORTED ON (B)(6) 2017 FROM (B)(6) MEDICAL CENTER THAT, "(B)(6) CALLED IN STATING THAT THE D850 SUDDENLY WENT INTO REVERSE TRENDELENBURG WITHOUT WARNING. NEED A TECH¿. AT THAT TIME, THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ASSOCIATED PROCEDURE. ON MARCH 5, 2020 STRYKER COMMUNICATIONS BECAME AWARE FOR THE FIRST TIME OF ALLEGED PATIENT INVOLVEMENT. IT IS ALLEGED IN A FILED LAWSUIT THAT A PATIENT WAS TO UNDERGO A DIAPHRAGMATIC HERNIA SURGERY AND THAT THE OPERATION TABLE MOVED INTO A REVERSE TRENDELENBURG POSITION AND THE PATIENT SLID DOWN AND/OR OFF THE TABLE CAUSING THE DOCTOR TO CATCH THE PATIENT. IT IS ALSO ALLEGED THAT THE SLIDING MOVEMENT CAUSED THE PATIENTS¿ BACK TO BECOME HYPER EXTENDED, AND THE PATIENTS¿ RIGHT KNEE TO COMPLETELY FLEX SO THAT THE PATIENTS¿S FOOT WAS CLOSE TO THE PATIENTS¿ HIP. THE SURGEON CHOSE TO ABORT THE SURGICAL PROCEDURE. IT IS FURTHER ALLEGED THAT PATIENT REQUIRED ADDITIONAL MEDICAL TREATMENT TO HER BACK SUBSEQUENT TO THE INCIDENT AT ISSUE. THE TABLE WAS INSPECTED ONSITE BY THE STRYKER FIELD SERVICE TECHNICIAN (FST) WHEN FIRST REPORTED. DURING THE INITIAL VISIT ON 1 SEPTEMBER 2017, THE FST REPORTED THAT WHILE CONDUCTING CYCLE TESTING OF THE TABLE WITH THE HAND PENDANT THAT WAS INSTALLED, SHE WAS ABLE TO REPLICATE THE UNINTENDED MOTION ISSUE TWICE, BUT THE EXACT ROOT CAUSE AS TO THE UNINTENDED MOVEMENT COULD NOT BE DETERMINED. THEREFORE, THE HAND PENDANT WAS REPLACED WITH (PART #106752, SERIAL #(B)(6)). AFTER ENSURING THAT THE REPLACEMENT HAND PENDANT WAS PROPERLY INSTALLED, CYCLE TESTING WAS PERFORMED, AND THE SURGICAL TABLE WAS FOUND TO BE OPERATING TO SPECIFICATION. THE ISSUE WAS RESOLVED, AND THE TABLE WAS PLACED BACK INTO SERVICE. THE MANUFACTURING DHR FOR THE DEVICE WAS REVIEWED. PAGE 6 OF THE DOCUMENT SHOWS THAT THE SURGICAL TABLE PASSED ALL FINAL TESTING AND QC CHECKS ON 6 AUGUST 2014. BOTH THE INSTALLATION AND SERVICE HISTORY FOR THE DEVICE WAS REVIEWED. THE SALES FORCE DATABASE SHOWED THAT THE SURGICAL TABLE WAS INSTALLED ON 3 NOVEMBER 2014. THERE WERE NO PRIOR SERVICE TICKETS FOUND FOR THIS DEVICE. ACCORDING TO THE FINDINGS REPORTED BY THE STRYKER FIELD SERVICE TECHNICIAN, THE ROOT CAUSE OF THE REPORTED ISSUE MAY BE RELATED TO THE HAND PENDANT. THE OPERON OPERATOR MANUAL (PART #57426, REVISION L), SECTION 8.2 (MAINTENANCE SCHEDULE) DESCRIBES THE MAINTENANCE WORK REQUIRED FOR OPTIMAL AND TROUBLE FREE OPERATION OF THE SURGICAL TABLE. THE INSTRUCTIONS ON PAGE 99 SPECIFICALLY STATE TO CHECK THE OPERATION OF THE HAND PENDANT TO MAKE SURE ALL FUNCTIONS ARE WORKING CORRECTLY, AND TO ENSURE NO DAMAGE IS PRESENT ON THE HAND PENDANT OVERALL, ON THE HAND PENDANT BUTTONS, OR ON THE HAND PENDANT CABLE AND THE CONNECTIONS. 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, ""GEORGE CALLED IN STATING THAT THE D850 SUDDENLY WENT INTO REVERSE TRENDELENBURG WITHOUT WARNING. NEED A TECH¿.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON (B)(6) 2017 FROM (B)(6) THAT, "(B)(6) CALLED IN STATING THAT THE D850 SUDDENLY WENT INTO REVERSE TRENDELENBURG WITHOUT WARNING. NEED A TECH¿. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR ASSOCIATED PROCEDURE. ON (B)(6) 2020 STRYKER COMMUNICATIONS BECAME AWARE FOR THE FIRST TIME OF ALLEGED PATIENT INVOLVEMENT. IT IS ALLEGED IN A FILED LAWSUIT THAT PATIENT WAS TO UNDERGO A DIAPHRAGMATIC HERNIA SURGERY AND THAT THE OPERATION TABLE MOVED INTO A REVERSE TRENDELENBURG POSITION AND THE PATIENT SLID DOWN AND/OR OFF THE TABLE CAUSING THE DOCTOR TO CATCH THE PATIENT. IT IS ALSO ALLEGED THAT THE SLIDING MOVEMENT CAUSED THE PATIENT¿S BACK TO BECOME HYPER-EXTENDED, AND THE PATIENT¿S RIGHT KNEE TO COMPLETELY FLEX SO THAT THE PATIENT¿S FOOT WAS CLOSE TO THE PATIENT¿S HIP. THE SURGEON CHOSE TO ABORT THE SURGICAL PROCEDURE. IT IS FURTHER ALLEGED THAT PATIENT REQUIRED ADDITIONAL MEDICAL TREATMENT TO HER BACK SUBSEQUENT TO THE INCIDENT AT ISSUE. STRYKER WILL FILE A SUPPLEMENTAL AT THE CONCLUSION OF THE INVESTIGATION OF THE NEWLY REPORTED CIRCUMSTANCES OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "(B)(6) CALLED IN STATING THAT THE D850 SUDDENLY WENT INTO REVERSE TRENDELENBURG WITHOUT WARNING. NEED A TECH¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327664 D 860 - CFK - POLYMER TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1