BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 18374608 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21605
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 30, 2023
    Report Date
    November 30, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA CAN BE FOUND IN SECTIONS A AND B.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN IMAGE WAS REVIEWED WHICH SHOWS THE STOMACH HAS BEEN STAPLED AND TRANSECTED. IT APPEARS THERE MAY BE SOME MALFORMED STAPLES AT THE DISTAL END OF THE LEFT SIDE OF THE STAPLE LINE THAT THE SURGEON HAS OVER-SEWN. THERE IS NO BLEEDING OR LEAKING FROM THE STAPLE LINE IN THE IMAGE. DURING SUBSEQUENT FOLLOW UP, THE SURGEON CLARIFIED THAT AFTER THE FIRST FIRE WITH A GREEN SUREFORM 60 RELOAD (INSTALL 1), SUBSEQUENT FIRES (INSTALLS 2-5) USED BLUE RELOADS WITH BUTTRESS MATERIAL. AFTER THE FIRING FAILURE, THE LOOSE STAPLES PRODUCED WERE REMOVED AND THE REMAINING FIRES WERE PERFORMED WITH NON-BUTTRESSED LOADS (INSTALLS 6 &7). UPON REINSPECTING THE STAPLE LINE, MULTIPLE EARLIER FIRES WITH BUTTRESS MATERIAL DEMONSTRATED LOOSE STAPLES - EVEN THE FIRE WITH NO PAUSES (INSTALL 4).THOUGH THERE WAS NO SIGNIFICANT BLEEDING NOTED, THE APPEARANCE OF THE STAPLE LINE WAS CONCERNING ENOUGH THAT THE ENTIRE STAPLE LINE WAS OVERSEWN. THE SURGEON IS UNCERTAIN IF THE GREEN SUREFORM 60 RELOAD (INSTALL 1) PRODUCED LOOSE STAPLES, BUT HE NOTICED THERE WERE MANY LOOSE STAPLES BELOW THE AREA OF THE MISFIRE WHILE OVERSEWING THAT AREA. HE NOTES THIS ADDITIONAL LOOSE STAPLES CORRESPOND WITH THE FIRE COMPLETED WITH NO PAUSES FOR COMPRESSION (INSTALL 4). THIS MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2023-21605) REPRESENTS THE FIRST BLUE SUREFORM 60 RELOAD. SEPARATE MEDWATCH REPORTS WERE SUBMITTED FOR CONCOMITANT PRODUCTS: MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2024-11689) FOR THE SECOND BLUE SUREFORM 60 RELOAD. MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2024-11691) FOR THE THIRD BLUE SUREFORM 60 RELOAD. MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2024-11693) FOR THE FOURTH BLUE SUREFORM 60 RELOAD. MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2024-11694) FOR THE FIFTH BLUE SUREFORM 60 RELOAD. MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2024-11703) FOR THE SIXTH BLUE SUREFORM 60 RELOAD. MEDWATCH REPORT (MFR REPORT NUMBER 2955842-2024-11688) FOR THE GREEN SUREFORM 60 RELOAD. CORRECTION: ANNEX E.

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. ADVANCED STAPLER LOGS SHOW THE INSTRUMENT WAS INSTALLED ON THE SYSTEM 7 TIMES AND FIRED 7 RELOADS (1 GREEN, FOLLOWED BY 6 BLUE). ON INSTALLS 1 AND 3, THE FIRINGS WERE COMPLETED WITH 1 PAUSE FOR COMPRESSION ON EACH. ON INSTALL 2, THE FIRST CLAMP ATTEMPT WAS ABORTED BY THE USER. THE 2ND CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 2 PAUSES FOR COMPRESSION. ON INSTALL 4, THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALLATION 5, THE FIRST 2 CLAMPS WERE SUCCESSFUL, BUT WERE FOLLOWED BY A FIRING FAILURE. ON INSTALLS 6 AND 7, THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED, AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE SYSTEM LOGS. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY, WHEN FIRING A BLUE SUREFORM 60 RELOAD WITH A SUREFORM 60 INSTRUMENT AND BUTTRESS MATERIAL, LOOSE STAPLES WERE FORMED. IT WAS STATED DURING FOLLOW UP WITH THE SURGEON, THROUGH THE CLINICAL SALES REPRESENTATIVE (CSR), THE STAPLES WERE NOT FULLY FORMED IN THE TISSUE, EACH WITH A VISIBLE GAP. THE LOOSE STAPLES WERE REMOVED AND ANOTHER BLUE SUREFORM 60 RELOAD WAS USED WITHOUT BUTTRESS MATERIAL TO COMPLETE THE STAPLE LINE. THE SURGEON OVERSEWED THE STAPLE LINE AND COMPLETED THE PROCEDURE ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153232 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-08 K12221204

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES