BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19491773 · Received June 7, 2024

    Report

    Report Number
    2955842-2024-14856
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 9, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE LARGE HEM-O-LOK CLIP APPLIER ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN INPUT DISK TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE BOTH GRIP INPUT DISKS BROKEN. INPUT DISKS #6 AND #7 WERE FOUND COMPLETELY BROKEN FROM THE INSIDE OF THE HOUSING. THIS CAUSED CLIPS NOT TO CLOSE SHUT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BARIATRIC REVISION AND PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, A CLIP APPLIED WITH THE LARGE CLIP APPLIER INSTRUMENT WOULD NOT CLOSE SHUT AND COULD NOT HOLD AROUND THE DUCT AND ARTERY. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED WITH NOTHING OUT OF THE ORDINARY REPORTED. THE INCIDENT OCCURRED WHILE THE SURGEON ATTEMPTED TO CLAMP THE DUCT AND ARTERY. THE ISSUE WAS RELATED TO UNSUCCESSFUL CLIP APPLICATION. THE CLIP DID NOT CLOSE COMPLETELY AROUND THE ARTERY AND DUCT, AND IT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. TELEFLEX LIGATION CLIPS WERE USED. THE SIZE OF THE CLIPS WAS LARGE. THE TARGET ANATOMY WAS NOT GREATER THAN 13MM IN DIAMETER. THE ISSUE OCCURRED AT THE FIRST CLIP APPLICATION.

    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
    998837 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K10220404 0030 00886874112380

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES