BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 25074423 · Received May 4, 2026

    Report

    Report Number
    2955842-2026-23717
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 4, 2026
    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
    PA, US
    Reporter Occupation
    501

    Narratives

    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 FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE LOWER JAW. THE MISSING FRAGMENT FROM THE MOLDED INSULATOR MEASURED APPROXIMATELY 0.95 MM X 7.85 MM, CONFIRMING THAT A PIECE DETACHED FROM THE INSTRUMENT AND WAS NOT RETURNED. THE GRIP BASE ASSOCIATED WITH THE CRACKED MOLDED INSULATOR DID NOT APPEAR TO BE BENT. ADDITIONAL FINDINGS SHOWED THAT THE INSTRUMENT HAD A DETACHED FRAGMENT FROM THE MOLDED INSULATOR THAT WAS NOT RETURNED, AND THE LOWER GRIP TIP BECAME DETACHED AS A RESULT OF THE BREAK IN THE 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, OR REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER NOTICED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN TIP. THE USER CONTINUED AND COMPLETED THE PROCEDURE AS PLANNED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT MATERIAL WAS DETACHED OR MISSING FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT¿S BODY. HOWEVER, IT WAS STATED THAT THE INCIDENT DID NOT INVOLVE A FRAGMENT FALLING INSIDE PATIENT ANATOMY. THE REPORTER ALSO CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300741 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-52 S10210714 0016 00886874114339

    Patients

    Seq Age Sex Outcome Treatment
    1