BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24715892 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19289
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    December 31, 2024
    Report Date
    March 27, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ACCESSORY INVOLVED WITH THIS COMPLAINT AND FOUND THE DRAPE WAS FOUND TO HAVE A LABYRINTH SEIZING/STICKING/FRICTION ISSUE PREVENTING INSTALLATION/ROTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE AFTER THE FIRST INSTRUMENT ARM DRAPE, THE CUSTOMER REPLACED IT AND SET IT AGAIN. THE CUSTOMER TRIED TO TURN THE BOOM HEAD AGAIN, BUT IT DID NOT TURN AT ALL. THE CUSTOMER IMMEDIATELY CALLED THE INTUITIVE SURGICAL REPRESENTATIVE NUMBER AND RELAYED THE SITUATION. AT THE SAME TIME, THE SCRUB NURSE REMOVED ALL THE DISCS OF THE INSTRUMENT ARM DRAPE AND REASSEMBLED THEM. HOWEVER, THE BOOM DID NOT TURN. THE CUSTOMER TOOK OUT THE DRAPE OF THE BOOM HEAD AGAIN, REASSEMBLED IT, AND TESTED IT. IT DID NOT WORK. THE CUSTOMER COMPLETELY TURNED OFF THE ROBOT SINGLE PORT (SP) SYSTEM AND TRIED AGAIN AFTER REBOOTING IT. IT DID NOT WORK. THE INTUITIVE SURGICAL REPRESENTATIVE NUMBER INSTRUCTED ME TO REPLACE IT WITH AN SP INSTRUMENT ARM DRAPE WITH A DIFFERENT SERIAL NUMBER AND TRY DRAPING. WHEN I DID AS RECOMMENDED, THE ROBOT WORKED. THE CUSTOMER WAS INFORMED THAT THERE WERE DEFECTS OCCURRING WORLDWIDE WHERE THE HEAD OF THE SP ROBOT INSTRUMENT ARM DRAPE DOES NOT TURN. THIS PROCESS TOOK ABOUT AN HOUR AND A HALF WITH THE PATIENT'S ABDOMEN OPEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595295 NONE INSTRUMENT ARM DRAPE NAY INTUITIVE SURGICAL, INC 430013-13 3164LAA800 00886874113486

    Patients

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