BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21728904 · Received March 31, 2025

    Report

    Report Number
    2955842-2025-12136
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119778
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE CADIERE FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.6775" X 0.2030" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN GRIP DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT SHAFTS AND/OR TIPS DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE TIP OF THE CADIERE FORCEPS INSTRUMENT COMPLETELY BROKE OFF DURING CLEANING. NOT DURING PROCEDURAL CARE SO NO FRAGMENTS INSIDE A PATIENT. 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: AS STATED, NOT DURING TIME OF PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009896 ENDOWRIST CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 471049-08 K11250109 0020 00886874119778

    Patients

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