BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19569426 · Received June 19, 2024

    Report

    Report Number
    2955842-2024-15935
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE VESSEL SEALER EXTEND INSTRUMENT BE RETURNED TO PERFORM FAILURE ANALYSIS. HOWEVER, AS OF THE DATE OF THIS REPORT, THE PRODUCT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE TO THE TIP OF THE VESSEL SEALER EXTEND INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH THE FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENTS CORD WAS CUT SO THE FUNCTIONAL TEST WAS NOT POSSIBLE. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE TIP OF THE VESSEL SEALER EXTEND INSTRUMENT HAD A SHARP SURFACE THAT TENDS TO HOOK INTO TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP OF THE VESSEL SEALER EXTEND INSTRUMENT HAD A SHARP EDGE AND WAS SHARP RIGHT FROM THE START. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING PROCEDURE. THE INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION. NO PHOTOS OR IMAGES WERE AVAILABLE FOR REVIEW. THE PART # AND LOT # ARE 480422-01/K15231102. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME INSTRUMENT. NO UNEXPECTED BLEEDING WAS EXPERIENCED BY THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673782 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K15231102 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES