BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18132550 · Received November 14, 2023

    Report

    Report Number
    2955842-2023-20268
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 19, 2023
    Report Date
    October 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION AND ADVANCED FAILURE ANALYSIS (AFA) WAS COMPLETED. INITIAL FINDINGS WERE CONFIRMED. RESISTANCE WAS OBSERVED WHEN THE GRIPS OPENED OR CLOSED, AND A CLOSER LOOK REVEALED THAT IT WAS DUE TO THE MECHANICAL DAMAGE FOUND ON THE BLADE. ADDITIONAL FINDINGS: THE INSTRUMENT EXHIBITED SLIGHTLY IMPRECISE MOTION WHEN TESTED ON THE SYSTEM. THE HOUSING WAS REMOVED, AND A LOOSE GRIP CABLE WAS OBSERVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO BE RETURNED WITH STUCK GRIP-TIPS (WRIST ASSEMBLY). GRIP INPUTS WERE MANUALLY ARTICULATED AND THE GRIP-TIPS DID NOT MOVE. NO CABLE BREAKAGE OR DAMAGE WAS OBSERVED INSIDE THE HOUSING. THE WRIST ASSEMBLY WAS MANIPULATED, AN ALL AXES WERE ABLE TO MOVE IN ALL DIRECTIONS. THE INSTRUMENT WAS INSTALLED ON IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT TESTS, MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. CUT TEST COULD BE PERFORMED WITH NO ISSUE. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE AN EXCESSIVE AMOUNT OF DRIED RESIDUE AROUND THE CLAMPING PULLEY CABLE GROOVES. THE INSTRUMENT WAS ALSO FOUND TO HAVE BLADE DAMAGE. ONE OF THE BLADE EDGES WAS INDENTED. THE INSTRUMENT HAD CORROSION ON THE GRIP-TIPS. BOTH GRIP TIPS EXHIBITED ORANGE DISCOLORATION. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HEAD OF THE MEGA SUTURECUT NEEDLE DRIVER MOVED DURING USE, AND IT WAS NOT FIXED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE INSTRUMENT MOVED NON-INTUITIVELY. THE MEGA SUTURECUT NEEDLE DRIVER DID NOT GRAB, AND THE NEEDLE WAS TWISTED. THE OPERATION WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY POSTOPERATIVE COMPLICATIONS.

    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
    1927041 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230817 0304 00886874119815

    Patients

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