BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 18253057 · Received December 1, 2023

    Report

    Report Number
    2955842-2023-20825
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 10, 2023
    Report Date
    November 10, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE PATIENT SIDE MANIPULATOR (PSM) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PSM WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION CONFIRMED BUT DID NOT REPRODUCE THE CUSTOMER REPORTED COMPLAINT. UPON RECEIVING THE PSM, THE RETENTION PLATE LEFT SPRING PIN WAS FOUND TO BE BROKEN. THE PSM WAS TESTED ON AN IN-HOUSE SYSTEM AND STARTED UP IN NORMAL MODE WITH NO ISSUE. THE SA AND THE INSTRUMENT WERE UNABLE TO ENGAGE DUE TO THE BROKEN PIN. HOWEVER, FA FOUND NO TROUBLE REMOVING INSTRUMENTS FROM THE SA. THE PSM FAILED THE PRELOAD SENSOR CHECK DUE TO INSTRUMENT ENGAGEMENT. THE PSM PASSED ALL OTHER TESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, AN INSTRUMENT WAS STUCK ON THE PATIENT SIDE MANIPULATOR (PSM) 3. THE CUSTOMER STATED THAT THE INSTRUMENT WAS NOT GRASPING TISSUE BUT WAS STUCK ON THE STERILE ADAPTER (SA). AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PRESS THE INSTRUMENT DISENGAGE BUTTON, WITH NO CHANGE. THE TSE THEN HAD THE CUSTOMER REMOVE ALL THE OTHER INSTRUMENTS AND RELEASE THE PSM 3 CANNULA FROM THE CANNULA MOUNT. THE CUSTOMER THEN REBOOTED THE SYSTEM, AND TRIED THE DISENGAGE BUTTON AGAIN, WITH NO CHANGE. THE CUSTOMER THEN USED A SMALL TOOL TO DISENGAGE THE INSTRUMENT OFF OF THE PSM. THE CUSTOMER THEN STATED THAT PSM 2 WOULD NOT ENGAGE INSTRUMENTS, AND THEY WERE NOT ABLE TO ATTACH THE DRAPE TO THE PSMS. THE TSE HAD THE CUSTOMER POWER DOWN THE SYSTEM, CYCLE THE PATIENT SIDE CART (PSC) BREAKER, AND PERFORM AN EMERGENCY POWER OFF (EPO). THE CUSTOMER POWERED ON THE SYSTEM, AND STILL WAS UNABLE TO DRAPE THE PSMS. THE CUSTOMER THEN STATED THAT A PIECE OF THE DRAPE FELL OFF. THE TSE ASKED THE CUSTOMER TO CHECK FOR RESIDUAL DRAPES ON THE PSMS AND ENSURE NONE WERE FOUND ON THE PSMS. THE CUSTOMER CONFIRMED NO DRAPES WERE ON THE PSMS. THE TSE HAD THE CUSTOMER POWER CYCLE THE SYSTEM AND RESTART. THERE WERE NO REPORTS OF PATIENT INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHEN THE SYSTEM WAS STARTED UP, IT APPEARED THAT EVERYTHING WAS FUNCTIONING PROPERLY. AFTER INSTALLING THE MONOPOLAR CURVED SCISSORS INSTRUMENT ON THE PSM3, THE CUSTOMER WAS UNABLE TO INSERT THE PSM INTO THE PATIENT. IT APPEARED TO BE STUCK. THE CUSTOMER WAS UNABLE TO REMOVE THE INSTRUMENT BY DEPRESSING THE RELEASE BUTTON ON THE SIDES. THE CUSTOMER STATED THERE WAS NO EMERGENCY KEY TO REMOVE THE INSTRUMENT. AFTER CALLING THE TECHNICAL SUPPORT, THE CUSTOMER WAS UNABLE TO REMOVE THE INSTRUMENT. THE CUSTOMER USED THE TIP OF A KELLY INSTRUMENT TO PUSH THE RELEASE BUTTON UP TO RELEASE THE MCS INSTRUMENT. A CADIERE FORCEPS INSTRUMENT WAS ATTACHED TO PSM 3. THE SYSTEM WAS SHUT DOWN AND STARTED UP AGAIN, STILL THE ISSUE PERSISTED. THE SYSTEM WAS POWER CYCLED BY SHUTTING OFF THE BASE, AND DEPRESSING THE RED BUTTON, AS INSTRUCTED BY THE TECHNICAL SUPPORT. AFTER THE SYSTEM WAS MOVED AWAY FROM THE PATIENT, IT WAS DECIDED THAT THE ISSUE WAS POSSIBLY DRAPE-RELATED. THE CUSTOMER MOVED THE SYSTEM AWAY FROM THE PATIENT AND REMOVED THE DRAPE. THE SYSTEM WAS SHUT OFF AGAIN AND RE-DRAPED. THE DRAPES DID NOT ALIGN. AFTER TURNING THE SYSTEM OFF AND ON AGAIN, THE PSMS MOVED AND WERE ALIGNED. THE PSMS COULD BE DRAPED. PSM 3 COULD NOT BE USED FOR THE PROCEDURE. THE SURGEON PROCEEDED WITH ONLY 2 PSMS WITH THE CAMERA. AN ACCESSORY PORT WAS USED. THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY DURING THE CASE OF OVER 1 HOUR. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504256 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-34 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES