BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21913900 · Received April 25, 2025

    Report

    Report Number
    2955842-2025-17293
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 26, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE 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. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGES PROVIDED APPEARED TO SHOW AN SP MCS WITH A BROKEN INSTRUMENT TUBE ADAPTER.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 6MM MONOPOLAR CURVED SCISSORS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN TUBE ADAPTER. THIS COMPONENT IS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND SERVES AS THE INTERFACE BETWEEN THE INSTRUMENT AND THE USER INSTALLED TIP ACCESSORY. THE BROKEN PIECE WAS NOT RETURNED AND MEASURES APPROXIMATELY 1.52MM X 2.16MM IN SIZE. ADDITIONAL FINDINGS: THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE DETACHED FRAGMENT BROKE OFF FROM THE INSTRUMENTS TUBE ADAPTER. THE DETACHED FRAGMENT WAS NOT RETURNED WITH THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE 6MM MONOPOLAR CURVED SCISSORS INSTRUMENT HAD A PLASTIC WREATH BROKE OFF AT THE BASE OF THE SCISSORS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: MATERIAL WAS REPORTEDLY MISSING FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT¿S BODY. THE PROTECTIVE COVER (ONE-OFF ITEM) WAS INTACT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755249 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-62 U10240702 0012 00886874114285

    Patients

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