BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFORM 60

    MDR report key: 13938318 · Received March 28, 2022

    Report

    Report Number
    MW5108560
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    March 24, 2022
    Report Date
    March 24, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 60 ROBOTIC STAPLER FIRED SUCCESSFULLY 4 TIMES THEN 60 ROBOTIC STAPLER ERROR INTRA-OPERATIVELY STATING: "NOT INITIALIZING - REINSERT STAPLER". REINSERTED MULTIPLE TIMES AFTER CLEANING STAPLER. ATTEMPTED WITH DIFFERENT COLORED STAPLE LOADS (WHITE/BLUE) READJUSTED ARM DRAPE, THEN REPLACED DRAPE. CONTINUED ERROR MESSAGE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784229 SUREFORM 60 SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 48/0460 T90220111

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male