BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 23492071 · Received November 6, 2025

    Report

    Report Number
    2955842-2025-42817
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    September 4, 2025
    Report Date
    February 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO A SEVERELY BENT GRIP NOTCH RESPONSIBLE FOR HOLDING THE CLIPS, RESULTING IN MISALIGNMENT OF THE GRIP TIPS. DUE TO THIS DAMAGE, THE CLIP COULD NOT BE PLACED PROPERLY. NO CRACKING OR DAMAGE WAS OBSERVED ON THE GRIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND HEMORRHAGIC SHOCK, NECESSITATING AN EMERGENCY REOPERATION. DURING THE INITIAL PROCEDURE, TWO CYSTIC ARTERIES WERE IDENTIFIED. AN ATTEMPT WAS MADE TO CLIP THE FIRST ARTERY WITH A MEDIUM-SIZED HEM-O-LOK CLIP, USING A MEDIUM-LARGE CLIP APPLIER INSTRUMENT. HOWEVER, THE CLIP WOULD NOT CLOSE AFTER SEVERAL ATTEMPTS. CONSEQUENTLY, A THIRD-PARTY LAPAROSCOPIC CLIP APPLIER WAS USED TO SUCCESSFULLY PLACE A METAL CLIP ON THE ARTERY. THE SECOND ARTERY WAS CLIPPED WITHOUT COMPLICATION USING A MEDIUM-SIZED HEM-O-LOK CLIP, AND ONE LARGE HEM-O-LOK CLIP. HEMOSTASIS WAS CONFIRMED OVER APPROXIMATELY 10 MINUTES PRIOR TO DRAIN PLACEMENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. THREE HOURS AFTER THE PROCEDURE, THE PATIENT DEVELOPED HEMORRHAGIC SHOCK AND REQUIRED AN EMERGENCY REOPERATION. INTRAOPERATIVELY, THE MEDIUM-SIZED HEM-O-LOK CLIP WAS OBSERVED TO BE CORRECTLY POSITIONED ON THE CYSTIC ARTERY; HOWEVER, ACTIVE BLEEDING WAS PRESENT DUE TO INCOMPLETE CLIP CLOSURE. AN AXON CLAMP WAS APPLIED TO THE CYSTIC ARTERY TO CONTROL THE BLEEDING, AND THE MEDIUM HEM-O-LOK CLIP WAS REMOVED WITHOUT RESISTANCE, INDICATING IMPROPER APPLICATION. HEMOSTASIS WAS SUBSEQUENTLY ACHIEVED BY SUTURING THE CYSTIC ARTERY WITH 5-0 PROLENE. THE ESTIMATED AMOUNT OF BLEEDING OR IF THE PATIENT REQUIRED A BLOOD TRANSFUSION, ARE UNKNOWN. THE PROCEDURE WAS COMPLETED, AND THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT HAS BEEN DISCHARGED, AND THERE IS NO CONCERN ABOUT THIS EVENT CAUSING ANY LONG-TERM COMPLICATIONS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568046 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K11230720 0094 00886874112465

    Patients

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