BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 18409028 · Received December 28, 2023

    Report

    Report Number
    2955842-2023-21640
    Event Type
    Injury
    Date Received
    December 28, 2023
    Report Date
    December 8, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    UDI-DI
    10886874116408
    PMA / PMN Number
    K181395
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE, BUT ISI HAS NOT RECEIVED A DEVICE FOR FAILURE ANALYSIS EVALUATION. REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE ALLEGED COMPLAINT THAT A PIECE OF THE CANNULA SEAL BROKE. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THE INNER SILICONE PORTION OF THE CANNULA SEAL BROKE OFF MID-CASE. IT SEEMED AS THOUGH WHEN CERTAIN INSTRUMENTS WERE INSERTED, A PIECE WOULD RIP OFF AND END UP INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401270 NONE SEAL GCJ INTUITIVE SURGICAL, INC 470500-13 U80230623 10886874116408

    Patients

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