BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17886048 · Received October 6, 2023

    Report

    Report Number
    2955842-2023-19026
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    March 30, 2023
    Report Date
    September 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A METALLIC FOREIGN OBJECT WAS FOUND IN THE SURGICAL FIELD, 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 MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND THE COMPLAINT REGARDING A FRAGMENT POTENTIALLY COMING FROM THE INSTRUMENT WAS NOT CONFIRMED BY FAILURE ANALYSIS. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE OR MISSING PIECES. THE INSTRUMENT WAS FOUND TO BE FULLY FUNCTIONAL WHEN TESTED ON AN IN-HOUSE SYSTEM AND MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY REVEALED RELATED RECORDS WITH PATIENT IDENTIFIER (B)(6) AND (B)(6) (IT WAS UNKNOWN WHICH OF THE 3 INSTRUMENTS USED IN THE PROCEDURE POTENTIALLY HAD A FRAGMENT FALL INTO THE PATIENT). .

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE MEGA NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE, WITH NO DAMAGE NOTED. THE FRAGMENT WAS SPOTTED AFTER THE SPECIMEN WAS REMOVED. THE SURGEON WAS UNSURE OF WHAT CAUSED THE ISSUE TO OCCUR. THE METALLIC FRAGMENT WAS FOUND APPROXIMATELY AN HOUR INTO THE PROCEDURE. THE SURGEON FOUND NO INSTRUMENT FUNCTIONALITY ISSUES. IT IS NOT BELIEVED THAT THE INSTRUMENT HAD ANY COLLISIONS. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE, BEFORE THE FRAGMENT WAS FOUND. THE WRIST WAS STRAIGHTENED PRIOR TO REMOVAL. NO RESISTANCE WAS FELT UPON REMOVAL. NO DAMAGE WAS FOUND TO THE CANNULA AFTER THE REPORTED EVENT OCCURRED. DAMAGE WAS NOT FOUND TO ANY OTHER INSTRUMENTS. AN EXPLORATORY LAPAROTOMY WAS NEEDED TO REMOVE THE FRAGMENT. AN X-RAY WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-OPERATIVE COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THAT WHEN PREPARING TO CLOSE THE VAGINAL CUFF, A METALLIC LOOKING ITEM APPROXIMATELY 2 CM LONG WAS FOUND INSIDE THE SURGICAL FIELD. WHEN THE SURGEON TRIED TO RETRIEVE THE ITEM, IT WAS REPORTEDLY LOST AND UNABLE TO BE FOUND. IT WAS UNKNOWN WHICH OF THE THREE INSTRUMENTS HAD A FRAGMENT FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202343 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-06 K10220627 0020 00886874112342

    Patients

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