BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22901556 · Received August 27, 2025

    Report

    Report Number
    2955842-2025-35767
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112496
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION- H8 UPDATED TO INDICATE INITIAL USE OF DEVICE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE INDENTATIONS/BURRS AT THE TIP OF THE GRIP TIPS. THE GRIPS WERE NOT FOUND TO BE BENT, AND ADDITIONAL DAMAGE WASN'T FOUND AT THE DISTAL END. COMPONENTS ADJACENT TO THE INDENTED GRIP TIPS DO NOT SHOW DAMAGE. THE COMPLAINT REGARDING TIP IS CHIPPED WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF NICKS AND GOUGES ON THE INSTRUMENT GRIP TIPS IS ATTRIBUTED TO DAMAGE DURING USE OR REPROCESSING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI), HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIP OF THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS CHIPPED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SINCE THERE IS NO CONFIRMATION THAT FRAGMENTS FELL INTO A PATIENT, NO SPECIFIC ACTIONS HAVE BEEN TAKEN IN RESPONSE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO THE RETENTION OF FOREIGN MATERIAL. THERE WAS A DISCREPANCY IN SURGICAL RECORDS, INDICATING THAT ON (B)(6) 2025, THE OPERATION WAS A PULMONARY LOBECTOMY NOT A DUODENAL SWITCH. INFORMATION WAS RECEIVED INDICATING THE INSTRUMENT WAS "CHIPPED," BUT THERE ARE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE DEVICES OR PROCEDURE AVAILABLE FOR ISI REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498048 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-11 K12240229 0058 00886874112496

    Patients

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