BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18378869 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21457
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    September 9, 2023
    Report Date
    November 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112274
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL ANALYSIS WAS PERFORMED ON THE MICRO BIPOLAR FORCEPS INSTRUMENT BY AN ADVANCED FAILURE ANALYSIS ENGINEER (AFAE). THE INITIAL FINDINGS WERE CONFIRMED. THE LOCALIZED MELTING NEAR THE GRIP BASES CAN BE CATEGORIZED AS THERMAL DAMAGE. FAE ATTEMPTED TO TRANSFER THE BROWN RUST-LIKE DEBRIS FROM THE INSTRUMENT TO FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) CRYSTAL BY SCRAPING OFF WITH A PAIR OF TWEEZERS AND WIPING WITH A COTTON SWAB AND ALCOHOL BUT NEITHER WORKED, SO THE COMPOSITIONAL ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MICRO BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS. INSPECTION FOUND A BROWNISH-RUST LIKE RESIDUE ON THE BIPOLAR YAW PULLEY. ADDITIONAL INSPECTION FOUND LOCALIZED MELTING NEAR THE GRIP BASE. THIS OBSERVATION IS UNRELATED TO THE PRIMARY ISSUE. THERMAL DAMAGE IS ATTRIBUTED TO CARBONIZED TISSUE ON THE GRIPS OF THIS BIPOLAR INSTRUMENT CREATING A CONDUCTIVE PATH DURING USE. THERMAL DAMAGE CAN ALSO RESULT DUE TO INADVERTENT ENERGY APPLICATION FROM A MONOPOLAR INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION, ENGAGEMENT, ENERGY DELIVERY AND ELECTRICAL CONTINUITY TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. 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

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MICRO BIPOLAR FORCEPS INSTRUMENT WAS INSPECTION AND A BROWN RUST-LIKE LIQUID LEAKED FROM THE TIP AND ADHERED TO THE INSULATION. THE CUSTOMER STATED THAT THE INSTRUMENT WAS NORMAL DURING THE LAST PROCEDURE USAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT DID NOT EXHIBIT ANY UNINTENDED ENERGY DISCHARGE. THE INSTRUMENT INVOLVED IN INADVERTENT CONTACT WITH ANOTHER HARD OBJECT OR INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT WAS INSPECTED BEFORE CENTRAL PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2051220 ENDOWRIST MICRO BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470171-14 N10180131 0047 00886874112274

    Patients

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