BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16925194 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13117
    Event Type
    Injury
    Date Received
    May 13, 2023
    Date of Event
    April 26, 2021
    Report Date
    May 4, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121504
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE 8MM LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A BROKEN GRIP TIP TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. BROKEN MATERIAL, APPROXIMATELY 0.30" X 0.09", WAS RETURNED BY THE CUSTOMER. NO MATERIAL APPEARED TO BE MISSING AS THE BROKEN ASSEMBLY WAS PIECED BACK TOGETHER. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA SURGICAL PROCEDURE, THE 8MM LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE AND A PIECE FELL OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN 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
    1352539 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-07 N10201130 0008 00886874121504

    Patients

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