BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24773091 · Received April 3, 2026

    Report

    Report Number
    2955842-2026-20344
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 18, 2026
    Report Date
    May 21, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874123461
    PMA / PMN Number
    K241814
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE SP MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. VISUAL INSPECTION WAS PERFORMED AND THE INSTRUMENT WAS OBSERVED TO HAVE A BROKEN LOWER MOLDED INSULATOR. THE BROKEN PIECE MEASURES APPROXIMATELY 1.1MM X 9.3MM AND WAS RETURNED WITH THE INSTRUMENT. HOWEVER, A SMALL, DETACHED FRAGMENT FROM THE LOWER MOLDED INSULATOR WAS MISSING. THE DETACHED FRAGMENT MEASURES APPROXIMATELY 0.32MM X 0.72MM. THE BROKEN LOWER MOLDED INSULATOR IS THE LIKELY CAUSE OF THE DETACHED FRAGMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEARED TO BE BENT. THERE WAS NO EXTERNAL DAMAGE TO THE SHAFT, HOUSING, AND SNAKE WRIST CABLES. EACH INPUT DISK WAS MANUALLY ARTICULATED AND RESPONDED ACCORDINGLY. THE RELEASE BUTTONS WERE FUNCTIONAL. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. ADDITIONAL OBSERVATION(S) RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE INSTRUMENT W OBSERVED TO HAVE DETACHED LOWER MOLDED INSULATOR FROM THE GRIP BASE. THE DETACHED FRAGMENT MEASURES APPROXIMATELY 1.1MM X 9.3MM AND WAS RETURNED WITH THE INSTRUMENT. HOWEVER, A SMALL, DETACHED FRAGMENT FROM THE LOWER MOLDED INSULATOR WAS MISSING. THE SMALL FRAGMENT MEASURES APPROXIMATELY 0.32MM X 0.72MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE DETACHED FRAGMENTS ARE LIKELY CAUSED BY THE BROKEN LOWER MOLDED INSULATOR. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THE IMAGE SHOWED AN SP MARYLAND BIPOLAR FORCEPS INSTRUMENT WITH A BROKEN MOLDED INSULATOR AND THERE COULD BE MISSING PIECES OF THE PLASTIC MOLDED INSULATOR: .

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PEDIATRIC PYELOPLASTY SURGICAL PROCEDURE, SP MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD MISALIGNED JAWS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124619 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430152-02 K10250408 00886874123461

    Patients

    Seq Age Sex Outcome Treatment
    1