BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 14467672 · Received May 23, 2022

    Report

    Report Number
    2955842-2022-11774
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    February 16, 2021
    Report Date
    February 16, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ISI RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED BLADE TIP DISCOLORATION. IT WAS NOTED THAT DISCOLORATION OF THE BLADE TIP IS A COMPONENT FAILURE THAT OCCURS AS A RESULT OF CAUTERY ACTIVATION AND IS UNRELATED TO THE REPORTED INJURY AS DISCOLORATION DOES NOT AFFECT THE DEVICE¿S PERFORMANCE. A REVIEW OF THE DEVICE LOGS FOR THE MONOPOLAR CURVED SCISSORS INSTRUMENT (PART #470179-19; LOT #N201110 0555) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS LAST USED ON (B)(6) 2021 VIA SYSTEM SERIAL #(B)(4). THERE WERE 9 USES REMAINING AFTER THIS LAST USAGE. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND REVEALED THAT THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. SEVERAL IMAGES WERE PROVIDED FOR REVIEW, WHICH CONFIRM DISCOLORATION OF THE INSTRUMENT SCISSORS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE INTERNAL ILIAC VEIN. AS A RESULT, THE VESSEL WAS REPAIRED WITH SUTURES AND VOLUME THERAPY WAS ADMINISTERED. IT WAS INDICATED THAT THE SURGEON/SITE BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS "SOME TISSUE GLUED AT THE VEIN," WHICH BY PULLING THE LYMPH NODES, RESULTED IN THE VEIN BECOMING DAMAGED. WHILE THERE IS NO EVIDENCE TO SUGGEST THAT A PRODUCT MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY RESULTED IN THE REPORTED-OPERATIVE COMPLICATION, THE CAUSE OF THE INTRAOPERATIVE COMPLICATION REMAINS UNKNOWN. AS A RESULT OF THE REPORTED COMPLICATION, THE SURGICAL PROCEDURE WAS DELAYED BY APPROXIMATELY 20 TO 30 MINUTES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, AFTER A DA VINCI-ASSISTED PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS OBSERVED TO BE DISCOLORED AT THE TIP. THE DISCOLORATION WAS UNABLE TO BE REMOVED DURING CENTRAL PROCESSING. IT WAS NOTED THAT AN UNSPECIFIED INTRA-OPERATIVE COMPLICATION OCCURRED DURING THE SURGICAL PROCEDURE WHICH RESULTED IN BLOOD LOSS OF 3 LITERS. ON 18-FEB-2021 AND 19-FEB-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: A PROGRASP FORCEPS INSTRUMENT, MARYLAND BIPOLAR FORCEPS INSTRUMENT, AND LARGE NEEDLE DRIVER INSTRUMENT WERE USED DURING THE PROCEDURE. THE DA VINCI SYSTEM, INSTRUMENTS, AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THERE WAS NO REPORT THAT A SYSTEM OR INSTRUMENT MALFUNCTION RESULTED IN THE MCS INSTRUMENT DISCOLORATION. THERE WERE NO OTHER MALFUNCTIONS OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO FRAGMENTS FELL INSIDE OF THE PATIENT'S ANATOMY. DURING THE LYMPHADENECTOMY ON THE RIGHT PELVIC AREA, THE FOLLOWING INTRA-OPERATIVE COMPLICATION OCCURRED: THE SURGEON "CAUSED A BLEEDING IN THE INTERNAL ILIAC VEIN." IT WAS INDICATED THAT THE SURGEON/SITE BELIEVE THE CAUSE OF THE PATIENT¿S OPERATIVE COMPLICATION, WAS "SOME TISSUE GLUED AT THE VEIN," WHICH BY PULLING THE LYMPH NODES, RESULTED IN THE VEIN BECOMING DAMAGED. THE BLOOD LOSS WAS APPROXIMATELY 2.2 LITERS AND WAS RESOLVED BY SUTURING THE VEIN. VOLUME THERAPY WAS PERFORMED WITH HYDROXYETHYL STARCH (HES), RINGER'S SOLUTION, AND ARTERENOL. IT WAS NOTED THAT THE R-R INTERVAL WAS ABOUT 90 SYSTOLIC DURING THE BLOOD LOSS. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION, AND THE SURGERY WAS COMPLETED ROBOTICALLY WITH A DELAY BETWEEN 20 TO 30 MINUTES. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT (ICU), AND THEN TO A NORMAL CARE UNIT AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582670 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 N12201110 0555 00886874112298

    Patients

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