BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM

    MDR report key: 18125934 · Received November 13, 2023

    Report

    Report Number
    2955842-2023-20226
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 11, 2023
    Report Date
    October 25, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874117085
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 45 BLUE RELOAD WAS ANALYZED AND FOUND TO HAVE LODGED MALFORMED STAPLES STUCK IN THE KNIFE TRACK AT THE DISTAL TIP OF THE RELOAD. THE STAPLES WERE SUCCESSFULLY REMOVED. THERE WERE ADDITIONAL OBSERVATIONS NOT REPORTED BY THE SITE AND RELATED TO THE PRIMARY FAILURE. THE RELOAD WAS DISASSEMBLED IN-HOUSE, AND THE CARTRIDGE APPEARED TO BE DAMAGED WITHIN THE KNIFE TRACK. THE DAMAGES WITHIN THE KNIFE TRACK WERE OBSERVED TOWARDS THE DISTAL END. THE RELOAD WAS FOUND TO HAVE BLADE DAMAGE WHEN THE RELOAD WAS DISASSEMBLED IN-HOUSE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A BLUE SUREFORM 45 RELOAD WITH NO ALLEGATIONS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204194 SUREFORM SUREFORM 45 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48345B-01 T10221117 10886874117085

    Patients

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