BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 20006487 · Received August 20, 2024

    Report

    Report Number
    2955842-2024-18225
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    July 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    UDI-DI
    10886874113834
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUREFORM 60 STAPLER AND TWO BLUE RELOADS WERE RECEIVED AND EVALUATED BY FAILURE ANALYSIS. THE SUREFORM 60 STAPLER INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED. THE TWO SUREFORM 60 BLUE RELOADS WERE RECEIVED, USED AND FIRED. THERE WERE NO SIGNS OF PHYSICAL DAMAGE TO THE CARTRIDGE, KNIFE, PUSHERS, OR COVER. NO PRODUCT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PRODUCT FOR FAILURE ANALYSIS INVESTIGATION. THE STAPLER LOGS FOR THE STAPLER USED IN THIS EVENT WERE REVIEWED AND THE FOLLOWING INFO WAS PROVIDED: LOGS SHOWED THE ASSOCIATED STAPLER WAS INSTALLED ON THE SYSTEM 8X AND FIRED 2 BLUE RELOADS. ON INSTALL 1, A BLUE RELOAD WAS LOADED, HOWEVER NO CLAMPING OR FIRING WAS ATTEMPTED. ON INSTALL 2, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. ON INSTALLS 3-6, THE STAPLER FAILED TO ENGAGE WITH THE SYSTEM. LOGS SHOW 4 INSTANCES OF ERROR CODE 22020, WITH PARAMETERS OF THE ERRORS INDICATING THAT THE WRIST PITCH AXIS FAILED TO ENGAGE ON EACH INSTALL ATTEMPT. ON INSTALL 7, THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 8, THE FIRST TWO CLAMPS WERE SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH NO PAUSES FOR COMPRESSION. THE INSTRUMENT WAS THEN REMOVED AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO ADDITIONAL STAPLER RELATED ERRORS IN THE LOGS. THE PROVIDED IMAGES WERE REVIEWED. THERE WAS A VESSEL SEALER EXTEND (VSE) HOLDING OPEN THE LUMEN OF UNSPECIFIED TISSUE. DUE TO THE QUALITY/ANGLE OF THE IMAGE, THE STAPLE LINE COULD NOT BE ASSESSED. ANOTHER IMAGE REVEALED PACKAGING FOR A SUREFORM 60 STAPLER AND A SINGLE SUREFORM 60 BLUE RELOAD. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    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 RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER FIRING A BLUE RELOAD HAD AN INCOMPLETE STAPLE LINE. THIS OCCURRED ON THE SECOND FIRING OF THE STAPLER. THE SURGEON USED A BACKUP STAPLER OF THE SAME TYPE TO CONTINUE WITH THE CASE. THE LUMEN WAS SUTURED TO REPAIR THE STAPLE LINE. NO BLEEDING WAS NOTED FROM THE COLON TISSUE. THE EVENT CAUSED A GREATER THAN THIRTY-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: WHILE TRANSECTING THE TRANSVERSE COLON IN PREPARATION OF A RIGHT COLON RESECTION, THE SUREFORM 60 STAPLER INSTRUMENT FIRING A BLUE RELOAD ON THE SECOND FIRING HAD AN INCOMPLETE STAPLE LINE. THE SURGEON EXPERIENCED NO TISSUE IRREGULARITIES ON THE TRANSVERSE COLON. NO STAPLES WERE NOTED IN THE TISSUE, IT WAS ONLY TRANSECTED. THE BLADE WAS NOT EXPOSED, AND NO STAPLES WERE MALFORMED. THE ENTIRE STAPLE LINE WAS MISSING. NO TISSUE WAS STUCK ON THE RELOAD. THE STAPLER DID NOT DISPLAY ANY ERROR MESSAGES. THE TEAM WAS ABLE TO USE A BACKUP STAPLER OF THE SAME TYPE TO COMPLETE THE CASE ROBOTICALLY. NO BLEEDING WAS OBSERVED FROM THE COLON AND NO UNPLANNED TISSUE REMOVAL OCCURRED DURING THE ANASTOMOSIS. THE COLON TISSUE WAS SUTURED TO REPAIR THE GAP. THE REPAIR REQUIRED MORE DISTAL DEBRIDEMENT AND DISTAL RE-STAPLING. THE EVENT DID CAUSE A PROLONGED CASE TIME. THE SURGEON STATED THAT POSSIBLY TOO MUCH TISSUE WITHIN THE JAWS COULD HAVE CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353749 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B-09 K10240222 10886874113834

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES