BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18728175 · Received February 17, 2024

    Report

    Report Number
    2955842-2024-11571
    Event Type
    Malfunction
    Date Received
    February 17, 2024
    Date of Event
    January 16, 2024
    Report Date
    January 23, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    ISIFA2022-01-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE LOGS FOR THE VESSEL SEALER EXTEND ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE LOGS SHOWED THAT THE FIRST INSTRUMENT VSE WAS INSTALLED 1X AND PASSED HOMING 1X. (B)(4) CUT COMPLETE EVENTS RECORDED WITH NO ERRORS. E100 LOGS SHOW (B)(4) SEAL EVENTS WITH (B)(4) HIGH INITIAL STARTING IMPEDANCE ERROR. THE SECOND INSTRUMENT VSE WAS INSTALLED 2X AND PASSED HOMING 2X. (B)(4) CUT COMPLETE EVENTS RECORDED WITH NO ERRORS. E100 LOGS SHOW (B)(4)SEAL EVENTS WITH (B)(4) HIGH INITIAL STARTING IMPEDANCE ERROR.

    Additional Manufacturer Narrative · 0

    THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE INSTRUMENT WAS FOUND TO HAVE A JELLIED SUBSTANCE AT THE DISTAL END. THE ROOT CAUSE OF THE ISSUE IS NOT ESTABLISHED. THE INSTRUMENT IS BEING FORWARDED TO ENGINEERING TO DETERMINE THE NATURE OF THE SUBSTANCE. A FAILURE ANALYSIS ENGINEER EVALUATED THE VSE INSTRUMENT AND THE JELLY-LIKE SUBSTANCE OBSERVED AT THE DISTAL END DURING INITIAL FA IS KRYTOX LUBRICANT, WHICH IS NOMINAL AND NOT EXCESSIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THERE WAS A WHITE JELLY SUBSTANCE NOTICED ALONG THE ARTICULATION TIP OF THE VESSEL SEALER EXTEND (VSE). THE CORD WAS CUT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED INTRAOPERATIVELY WHEN THE INSTRUMENT WAS USED. THE SURGEON TOOK A VIDEO OF THE ISSUE HAPPENING. ADDITIONALLY, THE SURGEON DID NOT BELIEVE ANY OF THE SUBSTANCE WAS LEFT INSIDE THE PATIENT BUT WAS NOT POSITIVE AS THEY HAD NEVER SEEN THAT BEFORE.

    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
    424355 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K10231116 0190

    Patients

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