BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 22119192 · Received May 30, 2025

    Report

    Report Number
    2955842-2025-23329
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR THAT MEASURED APPROXIMATELY 4.75MM X 9.10MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP TIP FROM THE UPPER MOLDED INSULATOR WAS ALSO NOT RETURNED. THE GRIP BASE ASSOCIATED WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. THE INSTRUMENT HAD A DETACHED FRAGMENT, WHICH INCLUDED THE BROKEN MOLDED INSULATOR AND GRIP. THE GRIP TIP FROM THE DETACHED FRAGMENT WAS NOT RETURNED. A BROKEN CONDUCTOR WIRE WAS OBSERVED AT THE GRIP BASE, WHICH IS BELIEVED TO HAVE RESULTED FROM THE BREAKAGE OF THE MOLDED INSULATOR. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF BROKEN MOLDED INSULATOR IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL. THE PROBABLE ROOT CAUSE OF DETACHED FRAGMENTS IS ATTRIBUTED TO BROKEN MOLDED INSULATOR AND GRIP. THE PROBABLE ROOT CAUSE OF BROKEN CONDUCTOR WIRE IS ATTRIBUTED TO BROKEN MOLDED INSULATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE CUSTOMER EXPERIENCED AN ISSUE WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT BROKE WHILE GRASPING TISSUE. THE ISSUE INVOLVED LIMITED OR IMPRECISE MOTION. THE INSTRUMENT WAS IDENTIFIED WITH A BROKEN CONDUCTOR WIRE. TWO WERE BROKEN WHERE THE TIP IS ATTACHED. ONE ALSO WAS BROKEN ON THE SHAFT WHERE INSTRUMENT IS WELDED TOGETHER.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12967 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10230324 0009 00886874114339

    Patients

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