BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 18137440 · Received November 15, 2023

    Report

    Report Number
    2955842-2023-20307
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 25, 2023
    Report Date
    October 25, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117115
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE SUREFORM 45 BLACK RELOAD TO PERFORM FAILURE ANALYSIS. THE RELOAD HAS ALREADY BEEN DISPOSED. ALTHOUGH THE COMPLAINT REGARDING THE PHYSICAL DAMAGE AND FRAGMENT ISSUE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE RELOAD WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM IN A RESEARCH AND DEVELOPMENT LAB, THE SUREFORM 45 BLACK RELOAD LEFT BEHIND TWO PIECES OF WHAT WAS PRESUMED TO BE YELLOW PUSHER MATERIAL ON THE STAPLE LINE. THIS WAS DURING AN EXCISED ANIMAL TISSUE LAB AND NO PATIENT INJURY OCCURRED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE RELOAD WAS DISCARDED. THIS WAS AN INTERNAL R&D LAB, AND THE PARTICULATE WAS OBSERVED BY CLINICAL DEVELOPMENT ENGINEERS, INCLUDING THE INITIAL REPORTER, PERFORMING THE LAB. FROM THEIR PERSPECTIVE, THERE WERE NO ABNORMAL CIRCUMSTANCES AROUND THIS FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912195 SUREFORM SUREFORM 45 RELOAD BLACK GDW INTUITIVE SURGICAL, INC 48345T-01 L80230524 10886874117115

    Patients

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