BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 17999895 · Received October 24, 2023

    Report

    Report Number
    2955842-2023-19568
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    September 26, 2023
    Report Date
    September 26, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113585
    PMA / PMN Number
    K152448
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS COULD NOT CONFIRM NOR REPLICATE THE REPORTED ISSUE. THE MEDIUM-LARGE CLIP APPLIER WAS DRIVEN ON AN IN-HOUSE SYSTEM AND 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. THERE WAS NO ISSUE WITH THE CLIPS ATTACHING TO THE INSTRUMENT OR CLAMPING. THE INSTRUMENT WAS FULLY FUNCTIONAL. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT RELEASE THE CLIP WHEN APPLYING IT ON A CYSTIC ARTERY. THE MEDIUM-LARGE CLIP APPLIER WOULD NOT ENGAGE ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1 OF THE PATIENT SIDE CART (PSC) AFTER IT WAS REMOVED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED ERROR 22020 ON USM1. THE TSE ASKED THE CUSTOMER TO RESEAT THE DRAPE ON USM1 AND TRIED ANOTHER INSTRUMENT. THE CUSTOMER WAS ABLE TO INSTALL A DIFFERENT INSTRUMENT SUCCESSFULLY ON USM1. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579432 SINGLE-SITE CLIP APPLIER, MEDIUM-LARGE NAY INTUITIVE SURGICAL, INC 478053-04 K10230323 0054 00886874113585

    Patients

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