BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21946409 · Received May 1, 2025

    Report

    Report Number
    2955842-2025-17934
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE SEVERELY BENT GRIP, CAUSING MISALIGNMENT OF THE GRIPS. A CLIP CANNOT BE PROPERLY LOADED ON THE GRIPS. THE GRIPS DO NOT SHOW CRACKING DAMAGE. COMPONENTS ADJACENT TO THIS SEVERELY BENT GRIP DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF SEVERELY BENT GRIPS IS ATTRIBUTED TO DAMAGE EITHER DURING USE OR REPROCESSING, AS SEVERE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO ACCIDENTAL DROPS, INCORRECT INSTRUMENT TRAY OR SINK SIZES FOR REPROCESSING, OR OVERLOADING THE TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS UNABLE TO SECURE CLIP FOR USE. SURGEON WAS UNABLE TO SECURE CLIP TO INTENDED TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE NOTED. THE CLIP APPLIER WAS UNABLE TO ATTACH CLIPS WHEN THEY WERE MOVED TO THE APPROPRIATE TISSUE. THE ISSUE IS NOT RELATED TO THE CLIP JAWS REMAINING STATIC, AND NO REPORT OF JAWS SWAYING SIDE TO SIDE. ISSUE WAS RELATED TO AN INCOMPLETE CLOSURE OF CLIP AS THE CLIP WOULD NOT REMAIN CLOSED. TWO CLIP APPLIERS WERE USED FOR EFFICIENCY. THE OTHER CLIP APPLIER DID NOT HAVE THE SAME ISSUE. HEM-O-LOK NON-ABSORBABLE POLYMER-LIGATING CLIPS WERE USED FOR THE PROCEDURE. THE BOAT AND RELOAD WERE MED/LARGE. THERE IS NO DOCUMENTATION REGARDING THE SPECIFIC DIAMETER OF THE TISSUE. THE TECH RECALLED "TWO OR THREE" ATTEMPTS TO USE THE CLIP APPLIER PRIOR TO USING THE SECOND CLIP APPLIER. A BACK UP CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192399 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 K11221016 0006 00886874112465

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.