BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 18504367 · Received January 12, 2024

    Report

    Report Number
    2955842-2024-10024
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 15, 2023
    Report Date
    December 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115647
    PMA / PMN Number
    K173721
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: AFTER THE FIRST STAPLER, THEY WANTED TO USE ANOTHER, BUT THEY HAD THE SAME ISSUE. THE PROCEDURE COULD NOT BE COMPLETED ROBOTICALLY. THE PROCEDURE WAS CONVERTED EXCLUSIVELY DUE TO THE SUREFORM STAPLER INSTRUMENT ISSUES. THE ENDO GIA STAPLER INSTRUMENT WAS USED IN LAPAROTOMY. REPORT WITH PATIENT IDENTIFIER 843491 DOCUMENTS THE OTHER SUREFORM 60 STAPLER. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUREFORM 60 STAPLER INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THE TEARS/TORN INSTRUMENT WRIST COVER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THE WRIST COVER TORN AT THE DISTAL END. THERE WAS NO MATERIAL MISSING. BASED ON THE INSTRUMENT LOGS, THE STAPLER INSTRUMENT WAS SUCCESSFULLY MOUNTED AND ENGAGED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE SUREFORM 60 STAPLER BECAME IMMOBILIZED UPON INSTALLATION TO THE IN-HOUSE SYSTEM DUE TO SEVERE DAMAGE ON THE WRIST COVER, RESULTING IN GETTING STUCK TO THE IN-HOUSE CANNULA. HOWEVER, AFTER THE REMOVAL OF THE DAMAGED WRIST COVER, THE INSTRUMENT EXHIBITED NO FURTHER COMPLICATIONS DURING INSTALLATION AND REMOVAL FROM THE SYSTEM. MOREOVER, THE INSTRUMENT SUCCESSFULLY EXECUTED CLAMPING, FIRING, AND UNCLAMPING OPERATIONS TWICE CONSECUTIVELY USING A GREEN SF 60 RELOAD.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 SURGICAL PROCEDURE, THE CUSTOMER WAS UNABLE TO INSERT THE SUREFORM 60 STAPLER INSTRUMENT THROUGH THE TROCAR. THE PROCEDURE WAS ABORTED OR CONVERTED DUE TO PATIENT ANATOMY WITH NO REPORTED INJURY. IT IS UNCLEAR IF THE CASE WAS ABORTED, CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY, OR CONVERTED TO OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002583 SUREFORM STAPLER 60 NAY INTUITIVE SURGICAL, INC 480460-09 L10230504 0560 10886874115647

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES