BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 17399989 · Received July 26, 2023

    Report

    Report Number
    2955842-2023-17317
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    June 27, 2023
    Report Date
    June 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 BLUE SUREFORM 60 RELOAD FIRED DURING THIS REPORTED EVENT FOR FAILURE ANALYSIS INVESTIGATIONS. THE SUREFORM 60 STAPLER INSTRUMENT LOGS SHOW (PART NUMBER 480460-09), (LOT NUMBER K13230420-0145), WAS INSTALLED ON THE SYSTEM 6X AND FIRED 6 RELOADS (1 BLACK, 1 GREEN, 3 BLUE, 1 GREEN, IN THAT ORDER). ON INSTALL 1, THE FIRST CLAMP WAS SUCCESSFUL AND THE FIRING WAS COMPLETED WITH 2 PAUSES FOR COMPRESSION. ON INSTALLS 2-4 AND 6, THE FIRST CLAMP WAS SUCCESSFUL AND THE FIRINGS WERE COMPLETED WITH NO PAUSES FOR COMPRESSION ON EACH. ON INSTALL 5, THE FIRST CLAMP WAS SUCCESSFUL, BUT WAS FOLLOWED BY A FIRING FAILURE, WHICH STOPPED AT 91% COMPLETION, AFTER A DURATION OF 90 SECONDS. MAX TORQUE RECORDED DURING THE FIRING WAS 587 N. THERE WERE NO INCOMPLETE CLAMPS OR INCOMPLETE UNCLAMPS FOR THIS INSTRUMENT. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE BLUE SUREFORM 60 RELOAD EXPERIENCED A TISSUE PUSHOUT ON STOMACH TISSUE, REQUIRING INTERVENTION. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION. THE SUREFORM 60 STAPLER INSTRUMENT WAS WORKING WITHOUT ISSUES PRIOR TO THE EVENT. THE SURGEON WAS ATTEMPTING TO COMPLETE THE FINAL FIRE ON STOMACH TISSUE WHEN THE EVENT OCCURRED. IT WAS NOTED THAT HALFWAY THROUGH THE FIRING SEQUENCE WITH THE BLUE RELOAD THE SUREFORM 60 STAPLER INSTRUMENT WAS CLAMPING AND COMPRESSING WHEN IT STARTED TO SLOW DOWN, EVEN STOPPED AND PAUSED MULTIPLE TIMES FOR COMPRESSION. ALTHOUGH THE SEQUENCE WENT THROUGH TO 95% THERE WAS TISSUE PUSHING AND BULDING FROM THE BLUE RELOAD. THIS LEFT THE STOMACH TISSUE WITH HALF A COMPLETE STAPLE LINE AND THE OTHER INTENDED STAPLE HALF LEFT A HOLE IN THE STOMACH. THE REMAINING HALF THAT DID NOT HAVE A COMPLETE STAPLE LINE, REQUIRING ADDITIONAL TISSUE RESECTION. THE STOMACH HOLE REQUIRED INTERVENTION WHICH INCLUDED THE SURGEON USING THE SAME SUREFORM 60 STAPLER INSTRUMENT WITH A NEW BLUE RELOAD CREATING A SUCCESSFUL NEW STAPLE LINE TO REPAIR THE DEFECT. THE SURGEON ALSO OVER-SUTURED THE NEW STAPLE LINE, AND USED VISTASEAL PRODUCT. DUE TO THIS TISSUE PUSHOUT EVENT, THE SURGEON ADDED A DRAIN THAT WAS LOCATED NEAR THE STAPLE LINE FOR ADDITIONAL OBSERVATION. NO LEAK TEST WAS PERFORMED DURING SURGERY, HOWEVER, POST-OPERATIVELY AN UPPER GI WAS COMPLETED WITH NO LEAK IDENTIFIED. NO BLOOD LOSS DUE TO THE EVENT. THE PATIENT IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654261 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B N/A

    Patients

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