BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 12209562 · Received July 22, 2021

    Report

    Report Number
    2955842-2021-10839
    Event Type
    Injury
    Date Received
    July 22, 2021
    Date of Event
    June 22, 2021
    Report Date
    June 22, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT "PIECE OF INSTRUMENT WAS NOTICED TO BE MISSING WHEN CHAR WAS BEING CLEANED OFF OF INSTRUMENT. A 'BLACK CONE' INSULATED PLASTIC PIECE NEAR THE HOOK IS MISSING." THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CERAMIC SLEEVE. A BROKEN PIECE MEASURING APPROXIMATELY 0.109¿ X 0.133¿ WAS MISSING AS A RESULT OF BREAKAGE AND WAS NOT RETURNED WITH THE INSTRUMENT. THE ROOT CAUSE OF A BROKEN INSTRUMENT CERAMIC SLEEVE IS TYPICALLY ATTRIBUTED TO MISHANDLING, SUCH AS EXCESS FORCE APPLIED TO THE DISTAL END OF THE INSTRUMENT OR ACCIDENTAL COLLISIONS. FAILURE ANALYSIS IDENTIFIED A SECONDARY FAILURE OF DISLODGED CERAMIC SLEEVE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE ROOT CAUSE OF A DISLODGED INSTRUMENT CERAMIC SLEEVE IS ATTRIBUTED TO MANUFACTURING. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A LOG REVIEW WAS PERFORMED AND FOUND THAT THE INSTRUMENT WAS LAST USED ON 22-JUNE-2021 ON SYSTEM SK1830 DURING A SIGMOID COLECTOMY PROCEDURE. THE PERMANENT CAUTERY HOOK HAD 5 USES REMAINING AFTER THE LAST USE, WITH A MAXIMUM OF 10 TOTAL USES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT A PIECE WAS MISSING FROM THE PERMANENT CAUTERY HOOK. IT WAS UNKNOWN IF THE BROKEN PIECE FELL INSIDE THE PATIENT AND WAS RETAINED. THE LOCATION OF THE MISSING FRAGMENT REMAINS UNKNOWN. THERE WAS NO KNOWN PATIENT INJURY AND THERE WAS NO REPORT OF THE PATIENT RETURNING DUE TO COMPLICATIONS FROM RETAINING A FOREIGN OBJECT. HOWEVER, IF THE FAILURE WERE TO RECUR IT COULD, IT COULD REQUIRE SURGICAL INTERVENTION AND CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A PLASTIC PIECE NEAR THE HOOK OF THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS MISSING WHILE THE CUSTOMER WAS CLEANING THE INSTRUMENT. IT WAS UNKNOWN IF A FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A ROBOTIC SIGMOID COLECTOMY. THE INSTRUMENT HAD BEEN IN USE FOR ABOUT AN HOUR, DISSECTING TISSUE, WHEN IT WAS REMOVED FROM THE PATIENT AND THE CHAR FROM BOVIE USAGE WAS BEING CLEANED OFF BY THE SCRUB TECH. HE SAID IT WAS DIFFICULT TO REMOVE SO HE USED A BLADE TO ASSIST. THAT IS WHEN HE NOTICED THAT THE CONNECTED AREA ON THE INSTRUMENT WHERE IT MEETS THE METAL HOOK WAS MOBILE ON THE HOOK AND A PIECE WAS MISSING. IT WAS UNKNOWN IF IT WAS INTACT PRIOR TO THAT OR WHEN IT HAD BROKEN. THE INSTRUMENT HAD REPORTEDLY FUNCTIONED APPROPRIATELY DURING THE SURGERY. THE SURGEON WAS NOTIFIED OF THE MISSING INSTRUMENT PIECE. THE PCH INSTRUMENT WAS REPLACED WITH A BACKUP INSTRUMENT AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL TESTS WERE PERFORMED. IT WAS UNKNOWN IF A FRAGMENT FROM THE PCH INSTRUMENT FELL INSIDE THE PATIENT'S ANATOMY AND WAS RETAINED. THE LOCATION OF THE MISSING PIECE FROM THE INSTRUMENT REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112245 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N10210308 0103 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES