BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20392799 · Received October 7, 2024

    Report

    Report Number
    2955842-2024-20175
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) WAS ANALYZED AND FOUND TO HAVE LOCALIZED MELTING ON THE TUBE EXTENSION AT THE ORANGE PLASTIC BENEATH. A REVIEW OF THE PROCEDURE LOGS CONFIRMED THERE WAS ANOTHER ENERGY PRODUCING INSTRUMENT IN THE PROCEDURE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE SUBMITTED FOR REVIEW AND A FAILURE ANALYSIS ENGINEER NOTED THERE APPEARS TO BE THERMAL DAMAGE TO THE TUBE EXTENSION OF THE MCS INSTRUMENT NEAR THE PROXIMAL CLEVIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS SENT FOR DISINFECTION AND WHEN THE MCS TIP COVER ACCESSORY WAS REMOVED, TWO BURN MARKS WERE IDENTIFIED. THE MEDICAL TEAM DID NOT REPORT ANY PROBLEMS DURING THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DAMAGE WAS VERIFIED AFTER THE END OF THE SURGERY BEFORE REPROCESSING. THE DAMAGE WAS TO THE INSTRUMENT. NO COLLISION WAS REPORTED DURING THE PROCEDURE. THE SURGEON DID NOT REPORT ANY PROBLEMS DURING THE SURGERY. NO ARCING WAS OBSERVED DURING THE PROCEDURE. THERE WERE NO PROBLEMS WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS INSTRUMENT IS AVAILABLE FOR RETURN TO ISI FOR EVALUATION. THE MCS TIP COVER ACCESSORY WAS DISCARDED, BUT NO DAMAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547783 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K14230413 0404 00886874112298

    Patients

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