BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 25020119 · Received April 28, 2026

    Report

    Report Number
    2955842-2026-22930
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 28, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113486
    PMA / PMN Number
    K182371
    Removal / Correction Number
    ISIFA2025-07-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT (SP) INSTRUMENT ARM DRAPE WAS ANALYZED AND FOUND TO HAVE ONE OF THE CLIPS ON THE OUTER LABYRINTH OF THE DRAPE BENT OUTWARDS. AS A RESULT THE DRAPE COULD NOT BE INSTALLED ONTO THE SYSTEM. THE COMPLAINT REGARDING THE CLIP ON THE CAMERA SIDE IS NOT ATTACHED WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, USER NOTICED THAT THE CLIP ON THE CAMERA SIDE OF THE SINGLE PORT (SP) INSTRUMENT ARM DRAPE WAS DETACHED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149760 NONE INSTRUMENT ARM DRAPE NAY INTUITIVE SURGICAL, INC 430013-15 1475LA0900 00886874113486

    Patients

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