BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 20968325 · Received December 18, 2024

    Report

    Report Number
    2955842-2024-23389
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 21, 2024
    Report Date
    November 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE THE SUREFORM 45 STAPLER INSTRUMENT OR RELOAD ACCESSORY THAT WAS USED DURING THIS REPORTED EVENT; THEREFORE, FAILURE ANALYSIS INVESTIGATIONS COULD NOT BE PERFORMED. ADVANCED STAPLER LOG REVIEW SHOWED: SUREFORM 45 STAPLER INSTRUMENT (LOT NUMBER: L13230223-0588) WAS USED FIRST, AND IT WAS INSTALLED ON THE SYSTEM 5 TIMES AND FIRED 5 GREEN RELOADS. ON INSTALL 1, THE FIRST 5 CLAMPS WERE INCOMPLETE. THE 6TH CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALL 2, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE GREEN SUREFORM 45 RELOAD ON THE SURGEON SIDE CONSOLE (SSC) TOUCHPAD. THE FIRST 4 CLAMPS WERE INCOMPLETE. THE 5TH CLAMP WAS SUCCESSFUL BUT WAS FOLLOWED BY A FIRING FAILURE. THE LOGS SHOW AN ERROR CODE, REPRESENTING THE FIRING FAILURE. ON INSTALL 3, THE FIRST CLAMP WAS SUCCESSFUL, BUT WAS FOLLOWED BY A SECOND FIRING FAILURE. ON INSTALL 4, FIRST CLAMP WAS SUCCESSFUL, BUT WAS FOLLOWED BY A THIRD FIRING FAILURE. ON INSTALL 5, FIRST CLAMP WAS SUCCESSFUL, BUT WAS FOLLOWED BY A FOURTH FIRING FAILURE. THE INSTRUMENT WAS THEN REMOVED AND NOT USED AGAIN IN THE PROCEDURE. SUREFORM 45 STAPLER INSTRUMENT (LOT NUMBER: L89230810-0459), WAS INSTALLED ON THE SYSTEM 2 TIMES AND FIRED 2 GREEN RELOADS. ON INSTALL 1, THERE WERE 9 INCOMPLETE CLAMP ATTEMPTS. THE 10TH CLAMP WAS SUCCESSFUL BUT WAS FOLLOWED BY A FIRING FAILURE. ON INSTALL 2, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE GREEN SUREFORM RELOAD ON THE SSC TOUCHPAD. THERE WERE 12 INCOMPLETE CLAMP ATTEMPTS. THE 13TH CLAMP WAS SUCCESSFUL BUT WAS FOLLOWED BY A FIRING FAILURE. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO ADDITIONAL STAPLER RELATED ERRORS IN THE LOGS. REFER TO MANUFACTURER REPORT NUMBER 2955842-2024-23388 FOR DOCUMENTATION OF THE OTHER STAPLER INVOLVED WITH THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT'S ANATOMY DID NOT ALLOW FOR THE CLAMPING OF A SUREFORM 45 STAPLER INSTRUMENT LOADED WITH A GREEN SUREFORM 45 RELOAD ACCESSORY; AND THE PROCEDURE HAD TO BE MODIFIED. PRIOR TO USE, THE SUREFORM 45 STAPLER INSTRUMENT WAS INSPECTED AND FOUND TO BE FREE OF DAMAGE OR ANY IRREGULARITIES. THE SURGEON USUALLY USES A GREEN RELOAD FOR USE ON THE RECTUM. THE SURGEON ATTEMPTED TO CLAMP THE PATIENT'S TISSUE TO PERFORM THE RECTUM TRANSECTION BUT WAS UNSUCCESSFUL AND RESORTED TO USING A BACKUP SUREFORM 45 STAPLER INSTRUMENT. A SECOND ATTEMPT WITH THE BACKUP INSTRUMENT, ALSO LOADED WITH A GREEN SUREFORM 45 RELOAD ACCESSORY, SIMILARLY THE STAPLER HAD A FIRING FAILURE, RESULTING IN AN EXPOSED BLADE. THE SURGEON THEN ATTEMPTED TO USE A "COELIO STAPLER"; HOWEVER, THE PATIENT TISSUE, COMPROMISED BY PRIOR RADIATION AND/OR CHEMOTHERAPY, DID NOT PERMIT STAPLING. DUE TO THE ISSUES WITH THE TECHNOLOGY AND TO RESOLVE THE ISSUE, THE SURGEON MODIFIED THE PROCEDURE AND PERFORMED A COLOANAL ANASTOMOSIS INSTEAD OF THE ORIGINALLY PLANNED COLORECTAL ANASTOMOSIS. THE PATIENT TOLERATED THE CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087920 SUREFORM SUREFORM 45 GDW INTUITIVE SURGICAL, INC 480445-04 N/A

    Patients

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