BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17890940 · Received October 6, 2023

    Report

    Report Number
    2955842-2023-19052
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    April 24, 2023
    Report Date
    September 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO EVIDENCE OF ARCING DURING PROCEDURE. A REVIEW OF THE ADVANCED FAILURE ANALYSIS INVESTIGATION FOR THE VESSEL SEALER EXTEND (VSE) INSTRUMENT ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCE FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ONLY LONG AUDIBLE TONES (UNSUCCESSFUL SEAL) WERE HEARD DURING TESTING. THIS FAILURE WOULD RESULT IN INSUFFICIENT/NO SEAL SINCE THE VSE INSTRUMENT WAS FAILING CONTINUITY.

    Additional Manufacturer Narrative · 0

    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 VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS ANALYZED ON AN IN-HOUSE SYSTEM, AND THE REPORTED FAILURE WAS CONFIRMED. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT. THE INSTRUMENT FAILED SEALING IN MULTIPLE ATTEMPTS. NO ERROR MESSAGE POPULATED WHEN ATTEMPTING TO SEAL. THERE WERE NO ERRORS REPORTED IN THE LOGS. AN INSPECTION OF THE HOUSING DID NOT REVEAL A LOOSE GRIP CABLE, AND A REVIEW OF LOGS DID NOT REVEAL ANY LOW TORQUE ERRORS THAT COULD POTENTIALLY EXPLAIN A SEALING MALFUNCTION. FURTHER INVESTIGATION FOUND THE INSTRUMENT FAILED CONTINUITY TEST FOR ONE OF THE JAWS. AN X-RAY INSPECTION OF THE JAWS REVEALED A BREAK IN THE CONDUCTOR WIRE AT WELD OF ONE OF THE JAWS, WHICH EXPLAINED WHY THE INSTRUMENT FAILED SEALING. 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 A DA VINCI-ASSISTED TRANSVERSE COLECTOMY SURGICAL PROCEDURE, AN ERROR MESSAGE APPEARED STATING THAT THE SEAL COULD NOT BE PERFORMED WHEN THE SURGEON TRIED CUT THE SEAL WITH THE VESSEL SEALER EXTEND (VSE). THE SITE CLEANED THE VSE INSTRUMENT JAWS AND TRIED AGAIN, BUT THE ISSUE WAS NOT RESOLVED. THE SITE USED A BACKUP VSE INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED 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
    219962 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L82230108 0355 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES