BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24439454 · Received February 25, 2026

    Report

    Report Number
    2955842-2026-07539
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113486
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: THE CUSTOMER RETURNED TWO NEW SINGLE-PORT ARM DRAPES AND 2 USED ONES. THERE WAS NO DAMAGE AND NOTHING WAS OUT OF THE ORDINARY. THE PROCEDURE WAS COMPLETED WITH A BACKUP DRAPE. THERE WAS NO INJURY TO THE PATIENT. THE SINGLE-PORT ARM DRAPES HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS NOT ABLE TO CONFIRM OR REPRODUCE THE REPORTED COMPLAINT. THE DRAPE WAS RETURNED BRAND NEW AND UNOPENED PACKAGING. THE INSTRUMENT ARM DRAPE WAS PLACED ON THE IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT WITHOUT ANY ISSUES. THE DRAPE SPIN TEST WAS PERFORMED AND PASSED. THE INNER AND OUTER LABYRINTH STAYED INTACT AND THERE WAS NO ABNORMAL NOISE OR FRICTION OBSERVED WHEN ROTATING THE INSTRUMENT DRIVES 180 DEGREES IN BOTH DIRECTIONS. THE ACCESSORY WAS FULLY FUNCTIONAL. VISUAL INSPECTION WAS PERFORMED AND THERE WAS NO DAMAGE FOUND.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SP DRAPES FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THE SINGLE-PORT (SP) ARM DRAPE KEPT DETACHING FROM THE THIRD ARM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612938 NONE INSTRUMENT ARM DRAPE NAY INTUITIVE SURGICAL, INC 430013-15 3365LA1400 00886874113486

    Patients

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