BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 13215370 · Received January 10, 2022

    Report

    Report Number
    2955842-2022-10032
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 14, 2021
    Report Date
    December 14, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION; HOWEVER, THE SITE STATED THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE VSE INSTRUMENT OCCURRED; HENCE, NONE OF THE INSTRUMENTS WILL BE RETURNED TO ISI FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. LOGS FOR THE VSE INSTRUMENT WERE REVIEWED: NO ERRORS RELEVANT TO THE VSE WERE FOUND WITHIN THE LOGS. THE INSTRUMENT APPEARS TO HAVE BEEN USED FOR APPROXIMATELY 6 MINUTES THROUGH 13 SEALS AND SIX CUTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS RELATED TO THIS PRODUCT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY, WHEN RESEALING THE IMA, THE AORTA WAS INJURED. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE, AND A VASCULAR SURGEON REPAIRED THE AORTA. BLOOD TRANSFUSION OF SIX UNITS OF RED BLOOD CELLS AND TWO UNITS OF FROZEN PLASMA WERE RENDERED TO THE PATIENT. ALTHOUGH THE SURGEON STATED THERE WAS NO MALFUNCTION WITH THE SEALING CYCLE, THE SURGEON PRESUMED THE IMA STUMP WAS BLEEDING AFTER USING THE VSE INSTRUMENT. THE SURGEON SPECULATED THAT WHEN SHE CAUTERIZED THE IMA STUMP AGAIN, SHE GOT TOO CLOSE TO THE AORTA AND INJURED IT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SURGEON THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY, THE SURGEON SEALED AND CUT THE INFERIOR MESENTERIC ARTERY (IMA) WITH THE VESSEL SEALER EXTEND (VSE) INSTRUMENT. THE SURGEON COMPLETED THE SEALING CYCLE WITH NO ISSUES. AFTER SHE CUT THE IMA, SHE NOTICED SOME BLEEDING. THE SURGEON PRESUMED THE IMA STUMP WAS BLEEDING. AS A RESULT, SHE CAUTERIZED THE PROXIMAL IMA STUMP, AND THE BLEEDING STOPPED. HOWEVER, WITHIN 30 SECONDS, THERE WAS EXCESSIVE BLEEDING, AND BLOOD FILLED THE SURGICAL FIELD. AS A RESULT, IMMEDIATELY, THE DA VINCI SYSTEM WAS UNDOCKED, AND THE PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE. ALTHOUGH THERE IS NO ALLEGATION THE VSE INSTRUMENT MALFUNCTIONED, THE SURGEON SUGGESTED THAT WHEN SHE CAUTERIZED THE IMA STUMP AGAIN, CLOSE OPERATING PROXIMITY TO THE AORTA MIGHT HAVE LED TO INJURY. A CUT WAS IDENTIFIED ON THE AORTA DURING THE OPEN PROCEDURE AND WAS REPAIRED BY A VASCULAR SURGEON. LUMBAR BLEEDING AND A MINOR BOWEL INJURY OCCURRED DURING THE OPEN PROCEDURE. THE AORTIC INJURY, THE LUMBAR BLEEDING, AND THE SMALL BOWEL SEROMA INJURY WERE ADDRESSED DURING THE OPEN PROCEDURE. A DIVERTING ILEOSTOMY WAS DONE TO PREVENT COMPLICATIONS SECONDARY TO EXCESSIVE BLEEDING. THE PATIENT HAD CODED AFTER THE PROCEDURE ON THE SAME NIGHT; HOWEVER, THE SURGEON STATED THE PATIENT IS RECOVERING "VERY WELL." THE ESTIMATED BLOOD LOSS WAS 3500 CC, AND SIX UNITS OF RED BLOOD CELLS AND TWO UNITS OF FROZEN PLASMA WERE ADMINISTERED TO THE PATIENT. THERE IS NO VIDEO RECORDING AVAILABLE FOR REVIEW. THE ESTIMATED BLOOD LOSS WAS 3500 CC, AND SIX UNITS OF RED BLOOD CELLS AND TWO UNITS OF FROZEN PLASMA WERE ADMINISTERED TO THE PATIENT. THERE IS NO VIDEO RECORDING AVAILABLE FOR REVIEW. ON A FOLLOW-UP WITH THE ROBOTICS COORDINATOR, IT WAS STATED THAT THERE WAS NO MALFUNCTION OF AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT, AND IT WAS A SURGEON-RELATED USE ERROR THAT WAS THE CAUSE OF THE INJURY. AS A RESULT, NONE OF THE DA VINCI INSTRUMENTS USED DURING THE PROCEDURE WILL BE RETURNED TO ISI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444451 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L92211004 0050 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES