BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24464763 · Received February 26, 2026

    Report

    Report Number
    2955842-2026-11944
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 26, 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
    JA
    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) DRAPE WAS ANALYZED AND FOUND TO THE STERILE ADAPTERS FOR EACH ARM CONNECTED AND PASSED RECOGNITION AND ENGAGEMENT. SPIN TEST WAS PERFORMED AND PASSED. THE DRAPES WERE INSTALLED WITH NO ISSUES OBSERVED. FOR CLARIFICATION, THE DRAPES WERE RETURNED WITH A DETACHED RING, HOWEVER AFTER RE-INSTALLING THE RING THE TESTING AND INSPECTIONS PASSED. A VISUAL INSPECTION WAS PERFORMED AND PASSED DUE TO NO VISUAL DAMAGE OBSERVED. THERE WAS NO PROBLEM DETECTED. THE COMPLAINT REGARDING THE RING COMES OFF WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE, THE RING-SHAPED ATTACHMENT PART ON THE SINGLE PORT (SP) DRAPE COMES OFF. UPON CLOSER INSPECTION, IT APPEARED THAT THE INNER LATTICE-LIKE PLASTIC WAS SUPPOSED TO ROTATE, BUT INSTEAD IT ROTATED ALONG WITH THE OUTER RING, CAUSING IT TO COME OFF THE DA VINCI ARM AND FALL OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE DRAPE CAME OFF MANY TIMES DURING THE PROCEDURE, BUT THEY USED THE SAME DRAPE DURING ENTIRE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512396 NONE INSTRUMENT ARM DRAPE NAY INTUITIVE SURGICAL, INC 430013-15 2395LA0400 00886874113486

    Patients

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