BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20860050 · Received December 6, 2024

    Report

    Report Number
    2955842-2024-22523
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 8, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE PROGRASP FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION TO INDICATE A REPROCESSING ISSUE. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHILE RETRACTING, THE PROGRASP FORCEPS INSTRUMENT BECAME LOCKED IN PLACE WITH ITS JAW BENT AT AN ANGLE AND WOULD NOT STRAIGHTEN OUT FOR REMOVAL FROM THE PATIENT. AS A RESULT, THE ASSISTING SURGEON GRASPED THE INSTRUMENT AND "YANKED" IT OUT OF THE PATIENT WITH NO INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 08-NOV-2024 FROM THE INITIAL REPORTER PROVIDED THE FOLLOWING INFORMATION: THE ISSUE OCCURRED WITH THE SURGEON'S HEAD INSIDE THE SURGEON CONSOLE'S HIGH RESOLUTION STEREO VIEWER (HRSV) , WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THE JAWS OF THE INSTRUMENT WERE STUCK ON THE BROAD LIGAMENT OF THE UTERUS WHEN THE ISSUE OCCURRED. THERE WAS SLIGHT TEARING TO THE GRASPED TISSUE. THERE WAS NO UNEXPECTED TISSUE REMOVAL, AND THE AFFECTED TISSUE WAS INSPECTED AND CAUTERIZED WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ON/IN THE FIELD. THERE WAS SOME BLEEDING AS A RESULT OF THE EVENT ESTIMATED TO BE LESS THAN 1 CC OF BLOOD LOSS. THE TISSUE HAD ALREADY BEEN DISSECTED FROM THE UTERUS AND THE SURGEON USED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266244 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K10231102 0190 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.