BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 15260067 · Received August 19, 2022

    Report

    Report Number
    2955842-2022-13527
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 20, 2022
    Report Date
    July 20, 2022
    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
    TX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT REFERENCED IN THIS COMPLAINT WAS NOT RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A LOG REVIEW CONFIRMED THE OCCURRENCE OF A PROCEDURE ON THE EVENT DATE OF 20-JUL-2022 ON SYSTEM SK4416. VERIFICATION VIA RFE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE OF 20-JUL-2022 ON SYSTEM SK4416 MATCHING THE DOCUMENTED EVENT DETAILS. THE INSTRUMENT LOGS WERE REVIEWED AND USAGE OF XI®/XI DUAL/X¿ STAPLER,SUREFORM 60 INSTRUMENT AND XI®/XI DUAL/X¿ ,SUREFORM 60,2.5 WHITE RELOAD WERE LOGGED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT STAPLES FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE STAPLES WERE RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. AT THIS TIME IT IS UNKNOWN WHAT CAUSED THE STAPLES TO FALL INTO THE PATIENT. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE STAPLER 30 INSTRUMENT INSTALLED WITH A WHITE RELOAD WAS INSTALLED INTO THE ARM AND WHEN THE USER OPENED THE INSTRUMENT JAWS, THE FORMED STAPLES FELL INTO THE PATIENT. THE SITE CLEARED OR RETRIEVED ALL OF THE STAPLES OUT. A NEW WHITE RELOAD WAS INSTALLED INTO THE SAME STAPLER INSTRUMENT WITH THE WHITE RELOAD WITH NO FURTHER ISSUES. THE SITE CONTINUED WITH THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY. THE REPORTED INFORMATION WAS FROM A 2ND HAND INFORMATION - A PERSON WHO WAS NOT PRESENT IN THE OPERATING ROOM. ISI CONDUCTED A FOLLOW UP AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE INTUITIVE CLINICAL SALES REP (CSR): THE STAPLER INSTRUMENT DID NOT FIRE. THE STAFF RETRIEVED THE STAPLES WITH LAPAROSCOPIC INSTRUMENTS. THERE WAS NO ADDITIONAL PROCEDURE NEEDED TO REMOVE THE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905332 SUREFORM STAPLER 60 RELOAD WHITE GDW INTUITIVE SURGICAL, INC 48360W

    Patients

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