BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 9729944 · Received February 19, 2020

    Report

    Report Number
    2955842-2020-10123
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 21, 2020
    Report Date
    January 29, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D10, G7, H1, H2, H3, H6, H8. 12- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED COMPLAINT OF ¿CABLE TORN.¿ THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING IN THE CLEVIS. THE CUSTOMER RETURNED A FRAGMENT WITH THE CRIMP STILL ATTACHED. THE INSTRUMENT HOUSING WAS REMOVED AND THE BROKEN PITCH CABLE WAS TAKEN OUT OF THE MAIN TUBE. THE BROKEN END OF THE PITCH CABLE WAS COMPARED TO THE END OF THE FRAGMENT RETURNED BY THE CUSTOMER, AND THEY WERE FOUND TO MATCH. VISUAL INSPECTION WAS CONDUCTED BY RUNNING THE BROKEN PITCH CABLE DOWN THE MAINTUBE AND IT WAS VERIFIED THAT NO OTHER PIECE OF THE PITCH CABLE WAS MISSING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    AN RMA HAS BEEN ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED; HOWEVER, ISI HAS NOT YET RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT FOR EVALUATION. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE RMA WITH NO SUCCESS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT HAD A TORN CABLE. IT WAS REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 2/4/2020 AND 2/10/2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PCH INSTRUMENT WAS VERIFIED PRIOR TO USE. THE PCH INSTRUMENT HAD BEEN IN USE FOR ABOUT ONE HOUR AND DID NOT COLLIDE WITH OTHER INSTRUMENTS. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT USING LAPAROSCOPIC FORCEPS. THERE WERE NO POST-OPERATIVE COMPLICATIONS. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENT'S CURRENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188975 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N10181218 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES