BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18880755 · Received March 11, 2024

    Report

    Report Number
    2955842-2024-12225
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 14, 2024
    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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VESSEL SEALER EXTEND INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). VISUAL INSPECTION FOUND NO DAMAGE TO THE INSTRUMENT. THERE WERE NO MELTED COMPONENTS IDENTIFIED ON THE INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT SUCCESSFULLY SEALED AND CUT. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. A REVIEW OF THE LOGS FOUND NO FAILURE ERRORS. AN ADDITIONAL OBSERVATION WAS MADE RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE COMPLAINT THAT "WHITE PIECES CAME OFF AND INTO THE PATIENT" WAS CONFIRMED. THE WHITE SUBSTANCE LOCATED AT THE DISTAL END OF THE INSTRUMENT HAS PREVIOUSLY BEEN IDENTIFIED BY MANUFACTURING AS KRYTOX LUBRICANT. THE PART WAS RETURNED WITH A REPORTED COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA SURGICAL PROCEDURE, THE AREA SURROUNDING THE JAWS OF A VESSEL SEALER EXTEND INSTRUMENT APPEARED TO HAVE MELTED. THE ISSUE SEEMS TO HAVE OCCURRED DURING THE CASE AS IT WAS NOT LIKE THIS WHEN THE INSTRUMENT WAS FIRST OPENED. WHITE PIECES CAME OFF AND INTO THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE ARE NOT AVAILABLE FOR ISI REVIEW. THE PATIENT DETAILS ARE CONFIDENTIAL AND WILL NOT BE PROVIDED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON SAID THAT THE OPERATION ROOM (OR) NURSE REPORTED THE COMPLAINT. THE SURGEON DID NOT THINK ANYTHING WAS MELTING, BUT MORE LIKELY THAT EXCESS LUBRICANT WAS EXTRUDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009798 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K12231014 0244 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES