BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 20663766 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21823
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 17, 2024
    Report Date
    October 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GCJ
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. CLINICAL SALES REPRESENTATIVE (CSR) HAD THE SITE REMOVE THE SCOPE FROM THE ARM, FLIP THE BASE AND PRESS THE INSTRUMENT CLUTCH BUTTON AND THEN THE IMAGE WORKED NORMAL. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, SCOPE IMAGE WAS UPSIDE DOWN. CLINICAL SALES REPRESENTATIVE (CSR) HAD THE SITE REMOVE THE SCOPE FROM THE ARM, FLIP THE BASE AND PRESS THE INSTRUMENT CLUTCH BUTTON AND THEN IMAGE WORKED NORMAL. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059540 NONE ENDOSCOPE GCJ INTUITIVE SURGICAL, INC 470067-10 N/A

    Patients

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