BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 17887441 · Received October 6, 2023

    Report

    Report Number
    2955842-2023-19037
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 5, 2023
    Report Date
    September 7, 2023
    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
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC (ISI) DID RECEIVE THE WHITE RELOAD DURING THIS REPORTED EVENT FOR FAILURE ANALYSIS INVESTIGATIONS. FAILURE ANALYSIS CONFIRMED THE REPORTED EVENT. THE RELOAD WAS FOUND TO HAVE THE KNIFE EXPOSED WITHIN THE KNIFE TRACK. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. THE BLADE EDGE WAS INDENTED, WHICH PREVENTS THE BLADES FROM CUTTING PROPERLY. THE RELOAD WAS FOUND TO HAVE CARTRIDGE DAMAGE. THE RELOAD CARTRIDGE HAD MECHANICAL INDENTATIONS. THERE WAS NO MATERIAL MISSING AS A RESULT. INTUITIVE SURGICAL, INC (ISI) DID RECEIVE THE SUREFORM 45 STAPLER INSTRUMENT DURING THIS REPORTED EVENT FOR FAILURE ANALYSIS INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE REPORTED EVENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS ON 3 OUT OF 3 ATTEMPTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT ALSO CLAMPED, FIRED, AND UNCLAMPED AS EXPECTED DURING TESTING. THE GRIP OPENED AND CLOSED PROPERLY. NO PHYSICAL DAMAGE WAS OBSERVED. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS IDENTIFIED.

    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 WHITE RELOAD DURING THIS REPORTED EVENT FOR FAILURE ANALYSIS INVESTIGATIONS. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE WHITE RELOAD WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE SUREFORM 45 STAPLER INSTRUMENT LOGS SHOW (PART NUMBER 480445-04), (LOT NUMBER L16230126-0603), WAS INSTALLED ON THE SYSTEM 1X AND FIRED 1 WHITE RELOAD. ON THE ONLY INSTALL, THE FIRST 4 CLAMP ATTEMPTS WERE INCOMPLETE, STOPPING AT 48%, 48%, 36%, AND 71%, RESPECTIVELY. THE 5TH CLAMP ATTEMPT WAS SUCCESSFUL, BUT WAS FOLLOWED BY A FIRING FAILURE. THE FIRING STOPPED AT 66% COMPLETION, AFTER A DURATION OF ~24 SECONDS. PEAK FIRING TORQUE WAS MEASURED AT 694 N. THE INSTRUMENT WAS THEN REMOVED, AND NOT USED IN THE PROCEDURE AGAIN. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. 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. FIELD H4 IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    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 NEPHRECTOMY SURGICAL PROCEDURE, THE SURGEON STATED THAT THAT THE WHITE RELOAD OF THE SUREFORM 45 STAPLER INSTRUMENT MALFUNCTIONED. THE SUREFORM 45 STAPLER INSTRUMENT CLAMPED DOWN AND THEN STOPPED AND APPEARED TO HAVE THE ERROR "TISSUE TOO THICK" WHILE ON THE RENAL ARTERY. THE SURGEON DID NOT WANT TO UNCLAMP THE STAPLER DUE TO THE RISK OF BLEEDING. A SECOND SURGEON SRUBBED IN, AND USED A LAPAROSCOPIC STAPLER TO COMPLETE THE STAPLE LINE. AFTER THE NEW STAPLE LINE WAS COMPLETE THE SURGEON WAS ABLE TO SUCCESSFUL UNCLAMPED THE SUREFORM 45 STAPLER INSTRUMENT FROM THE TISSUE, THERE WAS NO ADDITIONAL BLEEDING DUE TO THE EVENT. NO ADDITIONAL TISSUE RESECTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225626 SUREFORM SUREFORM 45 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48345W-01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES