BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 16448988 · Received February 27, 2023

    Report

    Report Number
    2955842-2023-10935
    Event Type
    Injury
    Date Received
    February 27, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 7, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED PRODUCT RELATED. INTUITIVE SURGICAL INC. (ISI) REQUESTED THE WHITE SUREFORM 60 RELOAD BE RETURNED FOR FAILURE ANALYSIS EVALUATION, BUT THE PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THE STAPLER LOGS FOR THIS EVENT WERE REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS ENGINEER (FAE): PER THE FAE, A SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED FIRST ON THE SYSTEM (ARM4) 2 TIMES AND FIRED 1 WHITE RELOAD. THERE WAS NO CLAMPING OR FIRING ATTEMPTED ON THE 1ST INSTALL. ON THE 2ND INSTALL, THERE WAS 1 SUCCESSFUL CLAMP, FOLLOWED BY A FIRING WITH 1 PAUSE FOR COMPRESSION. THERE WERE NO CLAMPING, UNCLAMPING, OR FIRING FAILURES FOR THIS INSTRUMENT. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS FOR THIS INSTRUMENT. NEXT, THE LOGS SHOW ANOTHER SUREFORM 60 STAPLER INSTRUMENT WAS INSTALLED ON THE SYSTEM (ARM4) 1 TIME AND FIRED 1 BLUE RELOAD. THERE WERE TWO SUCCESSFUL CLAMPS, FOLLOWED BY THE FIRING WITH NO PAUSES FOR COMPRESSION. THERE WERE NO CLAMPING, UNCLAMPING, OR FIRING FAILURES FOR THIS INSTRUMENT. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS FOR THIS INSTRUMENT. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A WHITE SUREFORM 60 RELOAD WAS FIRED AND THE STAPLE LINE BLED. THE SURGEON INTERVENED BY TYING THE BLEEDING VESSEL IN ORDER TO CONTROL THE BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, BLEEDING FROM AN UNSPECIFIED VESSEL WAS OBSERVED AFTER A WHITE SUREFORM 60 RELOAD WAS FIRED WITH A SUREFORM 60 STAPLER INSTRUMENT. THE SURGEON REPORTED TYING THE VESSEL TO RESOLVE THE BLEEDING. THE AMOUNT OF BLOOD LOSS WAS NOT PROVIDED. HOWEVER, THE BLEEDING WAS REPORTEDLY A SMALL AMOUNT BUT WAS MORE THAN EXPECTED. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE PROCEDURE WAS CONTINUED AS PLANNED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398379 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W-08 NA

    Patients

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