BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16541762 · Received March 14, 2023

    Report

    Report Number
    2955842-2023-11293
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 15, 2023
    Report Date
    February 17, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSTRUMENT STUCK ON TISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CADIERE FORCEPS INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE MULTIPLE INPUT DISK CRACKED. INPUT DISK #6 AND #7 WAS FOUND CRACKED INSIDE THE HOUSING. COMMON CAUSES OF THIS FAILURE MODE ARE TYPICALLY ATTRIBUTED TO THE MISHANDLING/MISUSE, SUCH AS IMPROPER CLEANING/REPROCESSING TECHNIQUES. THE INPUT DISK COMPONENT CONSISTS OF ULTEM MATERIAL INSERT MOLDED OVER A STEEL PIN. THE INSERT MOLDING PROCESS RESULTS IN RESIDUAL STRESS IN THE PLASTIC PORTION OF THE INPUT DISK. THESE RESIDUAL STRESSES CAN BE SUSCEPTIBLE TO CHEMICAL OR THERMAL STRESSES, WHICH CAN RESULT IN THE APPEARANCE OF CRACKS IN THE ULTEM MATERIAL. UNDER REPEATED OR PROLONGED CHEMICAL OR THERMAL EXPOSURE CYCLES, THESE CRACKS CAN PROPAGATE INTO LARGER CRACKS, AND MAY CAUSE THE INPUT DISK TO BREAK AND SEPARATE FROM THE INSTRUMENT. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS STUCK ON THE TISSUE AND THE CUSTOMER HAD TO USE THE KEY TO RECOVER THE INSTRUMENT. IT IS UNKNOWN IF THE CUSTOMER WAS ABLE TO RELEASE THE TISSUE. IT IS POSSIBLE THAT ENTRAPMENT OF TISSUE MAY HAVE OCCURRED. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE INSTRUMENT FAILS TO UNCLAMP/RELEASE FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS STUCK ON THE TISSUE AND THE CUSTOMER HAD TO USE THE KEY TO RECOVER THE INSTRUMENT. THE CART FROZE AND THE SYSTEM HAD TO REBOOT AND RESTART. A NEW INSTRUMENT WAS USED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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
    1478817 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 N12210719 0436

    Patients

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