BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19285579 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14380
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112670
    PMA / PMN Number
    K150837
    Removal / Correction Number
    ISIFA2022-05-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HORIZON SMALL CLIP APPLIER ASSOCIATED WITH THIS COMPLAINT, AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS COMPLETED. FA REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN INPUT DISK. INPUT DISK #7 WAS FOUND TO BE COMPLETELY DETACHED FROM THE BASE OF THE HOUSING. HAIRLINE CRACKS WERE FOUND ON INPUT DISK #6. AS A RESULT, THE GRIP CABLES LOST TENSION. THE OTHER BACKEND COMPONENTS ADJACENT TO THE BROKEN INPUTS DID NOT SHOW DAMAGE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRAOPERATIVE COMPLICATION CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INTERNAL MAMMARY ARTERY MOBILIZATION/HARVEST PROCEDURE, WHILE DISSECTING THE MAMMARY ARTERY, THE SURGEON ATTEMPTED TO CLIP THE COLLATERAL VESSEL USING THE SMALL CLIP APPLIER. WHILE THE SURGEON PINCHED HIS FINGER TO CLOSE THE INSTRUMENT TIPS AND DEPLOY THE CLIP, THE WRIST OF THE INSTRUMENT FLEXED 90 DEGREES, CAUSING THE JAWS OF THE INSTRUMENT TO SWAY TO THE SIDE. THE COLLATERAL VESSEL WAS CAUGHT IN THE WRIST OF THE INSTRUMENT AS A RESULT, AND IT WAS RELEASED WHEN THE SURGEON RELEASED HIS FINGERS. HOWEVER, THE COLLATERAL VESSEL WAS LACERATED, CAUSING MINOR BLEEDING. THE SAME ISSUE OCCURRED A SECOND TIME WITH THE SAME INSTRUMENT ON A DIFFERENT VESSEL. AFTER THE SECOND OCCURRENCE, THE SURGEON EXCHANGED THE INSTRUMENT FOR A BACK-UP SMALL CLIP APPLIER. THE ESTIMATED AMOUNT OF UNEXPECTED BLOOD LOSS WAS 100CC, AND NO BLOOD TRANSFUSIONS WERE REQUIRED. THE BLEEDING WAS CONTROLLED BY APPLYING A CLIP AT THE BASE OF THE COLLATERAL VESSEL. THERE WAS NO SERIOUS DETERIORATION OR CLINICAL INSTABILITY DURING THE TIME IT TOOK TO GET AND INSTALL A BACKUP CLIP APPLIER INSTRUMENT. THE ISSUE OCCURRED DURING CLIP APPLICATION, WHEN THE INSTRUMENT WAS IN THE PATIENT AND WHILE THE SURGEON ATTEMPTED TO CLAMP ON THE VESSEL. THE PROCEDURE WAS COMPLETED USING A BACK-UP INSTRUMENT OF THE SAME KIND, WITH A DELAY OF APPROXIMATELY 10 MINUTES. THERE ARE NO CONCERNS REGARDING LONG-TERM COMPLICATIONS FOR THIS PATIENT AS A RESULT OF THIS ISSUE; THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS OBSERVED. SMALL WECK HORIZON CLIPS WERE USED, AND THE SIZE OF THE VESSEL WAS NOT GREATER THAN THE SPECIFIED DIAMETER SUGGESTED IN THE INSTRUCTIONS FOR USE. THE CLIP APPLIER INSTRUMENT HAD BEEN USED MORE THAN 5 TIMES DURING THE PROCEDURE PRIOR TO THE EVENT. THE INSTRUMENT DID NOT APPEAR TO BE DAMAGED AFTER THE ISSUE OCCURRED. THE MOVEMENT OF THE INSTRUMENT WAS DESCRIBED AS UNINTUITIVE AND UNEXPECTED; THE ISSUE WAS NOT RELATED TO THE INSTRUMENT JAWS REMAINING STATIC WHEN THE SURGEON COMMANDED MOVEMENT, NOR TO THE CLIP OPENING AFTER IT HAD BEEN CLOSED. NO ANATOMICAL FACTORS CAUSED OR CONTRIBUTED TO THE BLEEDING. NO ADDITIONAL TISSUE WAS EXCISED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870987 ENDOWRIST CLIP APPLIER, SMALL, HORIZON NAY INTUITIVE SURGICAL, INC 470401-07 K10221002 0083 00886874112670

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES