BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON D 860 SEAT CFK STAINLESS

    MDR report key: 19667553 · Received July 3, 2024

    Report

    Report Number
    0008010153-2024-00013
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 6, 2024
    Report Date
    October 25, 2024
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    UDI-DI
    07613327170160
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED, "ST MARKS HOSP - IT WAS CALLED IN STATING THAT THE D860 TABLE (S/N: (B)(6)) RISED AND LEVELED WITHOUT ANYONE TOUCHING THE TABLE WHILE THE PATIENT WAS ON THE TABLE AND WITH TROCARS INSIDE THE BODY.", ADDITIONAL DETAILS PROVIDED WAS THAT "BY HIS RECOLLECTION, THE CASE WAS ALMOST FINISHED AND THEY WERE PREPARING TO REMOVE THE ROBOT WHEN SUDDENLY THE FOOT END OF THE TABLE ( THE TABLE WAS IN REVERSE TRENDELENBURG) STARTED TO LEVEL AND AFTER IT LEVELED OUT THE ENTIRE TABLE ROSE SLIGHTLY. THE ANESTHESIOLOGIST DID NOT HAVE THE CONTROL PENDANT IN THEIR HAND AND AS THE FOOT END STARTED TO RISE, THE ANESTHESIOLOGIST TOOK THE CONTROL PIECE AND TRIED TO STOP IT BUT IT DID NOT WORK. THE TROCARS WERE STILL IN THE PATIENT AND THE ROBOT ARMS WERE CONNECTED TO THOSE TROCARS. THERE WAS A CONCERN THAT THERE WAS SOME INTERNAL DAMAGE OR INJURY TO THE PATIENT FROM THE LEVELING. THE PHYSICIAN TOOK ABOUT 5 TO 8 MINUTES TO VERIFY THAT NO DAMAGE HAD BEEN DONE AND THAT THE CASE COULD BE COMPLETED SAFELY. AFTER VERIFYING THAT THE PATIENT WAS UNHARMED, THEY WERE ABLE TO COMPLETE THE CASE AND REMOVE THE ROBOT AND TROCARS. AFTER THE TABLE HAD LEVELED, IT LOCKED ITSELF INTO POSITION AND THEY WERE UNABLE TO UNLOCK OR ADJUST ANYTHING OR LOWER THE TABLE. HE THINKS HE REMEMBERS THAT THE TABLE WAS UNPLUGGED AT THE TIME AND SO THEY PLUGGED THE TABLE IN TO WALL OUTLET AND ANOTHER STAFF MEMBER WAS CALLED IN AFTER THE CASE FINISHED. THEY REPLACED THE CONTROL PENDANT WITH A DIFFERENT CONTROL PIECE FROM ANOTHER TABLE AND THEY WERE ABLE TO AT LEAST UNLOCK THE TABLE AND GET IT OUT OF THE ROOM AND INTO THE HALLWAY WHERE IT CURRENTLY IS." TO ADDRESS THIS ISSUE A STRYKER FIELD SERVICE TECHNICIAN WOULD NORMALLY BE SENT OUT. THE CUSTOMER WAS GIVEN A WORK ORDER QUOTE ON (B)(6) 2024 SINCE THE TABLE IS NO LONGER UNDER WARRANTY. SINCE THE WORK ORDER QUOTE HAS YET TO BE FILLED OUT AND A PO FOR THE SERVICE TECHNICIAN TO BE SENT, THERE IS NO ADDITIONAL INFORMATION AVAILABLE ON THE TABLE ITSELF. IF A PO IS PLACED AND A FIELD SERVICE TECHNICIAN IS ABLE TO PERFORM THE INVESTIGATION/REPAIR THEN THE COMPLAINT WILL BE UPDATED. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE AND THERE NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED. THIS FAILURE MODE HAS NOT EXCEEDED ANY THRESHOLD AND WILL CONTINUE TO BE MONITORED. SINCE THERE WAS NO SERVICE TECHNICIAN SENT OUT FOR FURTHER INVESTIGATION DUE TO A LACK OF A PO, THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE D860 TABLE RAISED AND LEVELED WITHOUT ANYONE TOUCHING THE TABLE WHILE THE PATIENT WAS ON THE TABLE AND WITH TROCARS INSIDE THE BODY. THE FOOT END OF THE TABLE (THE TABLE WAS IN REVERSE TRENDELENBURG) STARTED TO LEVEL AND AFTER IT LEVELED OUT THE ENTIRE TABLE ROSE SLIGHTLY. THE ANESTHESIOLOGIST DID NOT HAVE THE CONTROL PENDANT IN THEIR HAND AND AS THE FOOT END STARTED TO RISE, THE ANESTHESIOLOGIST TOOK THE CONTROL PIECE AND TRIED TO STOP IT BUT IT DID NOT WORK. THE PHYSICIAN TOOK ABOUT 5 TO 8 MINUTES TO VERIFY THAT NO DAMAGE HAD BEEN DONE AND THAT THE CASE COULD BE COMPLETED SAFELY. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE D860 TABLE RAISED AND LEVELED WITHOUT ANYONE TOUCHING THE TABLE WHILE THE PATIENT WAS ON THE TABLE AND WITH TROCARS INSIDE THE BODY. THE FOOT END OF THE TABLE (THE TABLE WAS IN REVERSE TRENDELENBURG) STARTED TO LEVEL AND AFTER IT LEVELED OUT THE ENTIRE TABLE ROSE SLIGHTLY. THE ANESTHESIOLOGIST DID NOT HAVE THE CONTROL PENDANT IN THEIR HAND AND AS THE FOOT END STARTED TO RISE, THE ANESTHESIOLOGIST TOOK THE CONTROL PIECE AND TRIED TO STOP IT BUT IT DID NOT WORK. THE PHYSICIAN TOOK ABOUT 5 TO 8 MINUTES TO VERIFY THAT NO DAMAGE HAD BEEN DONE AND THAT THE CASE COULD BE COMPLETED SAFELY. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683654 OPERON D 860 SEAT CFK STAINLESS TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG 07613327170160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown