BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 18856990 · Received March 7, 2024

    Report

    Report Number
    2955842-2024-11934
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROGRASP FORCEPS INSTRUMENT FOR FAILURE ANALYSIS TESTING. UPON VISUAL AND MICROSCOPIC INSPECTION, NO DAMAGE WAS FOUND TO THE WRIST ASSEMBLY. NO CABLE DAMAGE WAS OBSERVED. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY AND PERFORMED GRIP FUNCTION SUCCESSFULLY. THE GRIP BUMPER TEST PASSED AS WELL. FURTHER INSPECTION FOUND A DISLODGED FLUSH TUBE GUIDE UPON INSTRUMENT HOUSING REMOVAL. AS A RESULT, AN AUDIBLE RATTLING NOISE COULD BE HEARD FROM THE INSIDE OF THE HOUSING WHEN SHAKEN BECAUSE IT WAS NOT SECURED WITHIN THE CHASSIS. THIS FINDING WAS UNRELATED TO THE PRIMARY ISSUE. THE CUSTOMER REPORT OF DAMAGE AT THE INSTRUMENT TIP WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN CONNECTING THE PROGRASP FORCEPS INSTRUMENT TO THE ROBOT ARM, PART OF THE TIP BROKE. THE PROCEDURE WAS COMPLETED AS PLANNED USING A BACKUP PROGRASP FORCEPS INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A PART OF THE TIP BROKE OFF (DETACHED) AND FELL INSIDE THE PATIENT. WHEN THE BREAKAGE OCCURRED, THE FRAGMENT WAS IMMEDIATELY REMOVED DURING THE SAME SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195303 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K10220316 0236 00886874119785

    Patients

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