BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 15404030 · Received September 12, 2022

    Report

    Report Number
    2955842-2022-13959
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    August 12, 2022
    Report Date
    August 13, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112496
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON BELIEVES THAT THE CAUSE OF THE ARTERIAL DISSECTION IS DUE TO PRESSURE FROM THE TIP-UP FENESTRATED GRASPER INSTRUMENT. HOWEVER, THE SITE IS NOT RETURNING THE INSTRUMENT AS THE SURGEON STATED THAT THE CAUSE OF THE INCIDENT WAS NOT DUE TO A PRODUCT MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ALTHOUGH NONE OF THE REUSABLE INSTRUMENTS WERE REUSED IN SUBSEQUENT PROCEDURES, A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED APR PROCEDURE, THE RIGHT EIA WAS DISSECTED, POSSIBLY DUE TO PRESSURE FROM THE SHAFT OF THE TIP-UP FENESTRATED GRASPER INSTRUMENT. ENDARTERECTOMY AND INTIMAL REPAIR OF THE DISSECTED SITE WERE PERFORMED IN A SUBSEQUENT PROCEDURE VIA OPEN SURGERY BY THE CARDIOVASCULAR SURGEONS. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AND AN UNPLANNED STAY IN THE ICU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINO PERINEAL RESECTION (APR) PROCEDURE, THE RIGHT EXTERNAL ILIAC ARTERY (EIA) HAD A DISSECTION INJURY, POSSIBLY DUE TO PRESSURE FROM THE TIP-UP FENESTRATED GRASPER INSTRUMENT. ENDARTERECTOMY AND INTIMAL REPAIR OF THE DISSECTED SITE WERE PERFORMED IN A SECOND PROCEDURE BY CARDIOVASCULAR SURGERY VIA OPEN SURGERY. ACCORDING TO THE SURGEON, IT IS BELIEVED THAT THERE WILL BE NO SIGNIFICANT IMPACT ON THE PROGNOSIS OF LIFE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: AFTER THE PATIENT WAS TRANSFERRED TO THE WARD POST-OPERATIVELY, AN UNSPECIFIED ABNORMALITY WAS NOTICED DURING PATIENT MONITORING WHICH LED TO THE SURGEONS REVIEWING THE PROCEDURE VIDEO. THE PROCEDURE VIDEO SHOWED PULSATION OF A VESSEL AND A DISSECTION OF THE RIGHT EIA WHICH HAD OCCURRED DURING THE PRIMARY PROCEDURE WAS SUSPECTED. THE SURGEON BELIEVES THAT WHEN HE WAS DISSECTING THE RIGHT WALL OF THE RECTUM, THE SHAFT OF THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS TOUCHING THE RIGHT PELVIC WALL AND PRESSED AGAINST THE RIGHT EIA, WHICH CAUSED THE INJURY TO THE VESSEL. THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS NOT USED TO RETRACT OR GRASP THE EIA AND THE VESSEL WAS NOT ACCIDENTALLY DISSECTED. THE SURGEON STATED THE HOSPITAL IS NOT RETURNING THE TIP-UP FENESTRATED GRASPER INSTRUMENT AS THEY BELIEVE THE CAUSE OF THE INJURY WAS NOT DUE TO AN INSTRUMENT FAILURE. THE INJURY WAS REPAIRED BY ENDOTHELIAL RESECTION AND INNER MEMBRANE REPAIR AT THE DISSOCIATED SITES. THE ESTIMATED BLOOD LOSS WAS ENQUIRED BUT NOT PROVIDED. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE PATIENT HAD AN UNPLANNED ADMISSION TO THE ICU AND PROLONGED HOSPITALIZATION. PHOTOGRAPHIC IMAGES AND VIDEO OF THE PROCEDURE ARE NOT AVAILABLE FOR ISI TO REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215333 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-12 U12220310 00886874112496

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES