BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 19074662 · Received April 9, 2024

    Report

    Report Number
    2955842-2024-13192
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 8, 2024
    Report Date
    March 15, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115647
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRAOPERATIVE COMPLICATION CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION. A REVIEW OF THE DEVICE LOGS FOR THE SUREFORM 60 STAPLER INSTRUMENT ASSOCIATED WITH THIS EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, THE LOGS SHOW THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 3 TIMES, AND IT FIRED 1 BLUE RELOAD. ON INSTALLS 1 AND 2, THE STAPLER FAILED TO ENGAGE WITH THE SYSTEM. THE SYSTEM LOGS SHOW 2 INSTANCES OF ERROR CODE 22020, WITH PARAMETERS INDICATING THAT THE GRIP AXIS FAILED TO ENGAGE. ON THE THIRD INSTALL, THE STAPLER ENGAGED, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE STAPLER WAS THEN REMOVED, AND IT WAS NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO ADDITIONAL STAPLER RELATED ERRORS IN THE SYSTEM LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT DID NOT WORK PROPERLY, AND THERE WAS BLEEDING AS A RESULT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511902 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 L87230706 0483 10886874115647

    Patients

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