BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION

    MDR report key: 14877555 · Received June 30, 2022

    Report

    Report Number
    2955842-2022-12679
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 7, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    00886874116234
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION WAS TRACED TO COMPONENT FAILURE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE FAILURE ANALYSIS EVALUATION. FAILURE ANALYSIS CONFIRMED AND REPLICATED THE "CATHETER POPPED OFF FLEXIBLE INSTRUMENT MANIPULATOR (FIM)" EVENT. THE UNIT WAS INSTALLED ON THE IN-HOUSE SYSTEM, AND IT PASSED SELF-TEST WITHOUT TRIGGERING ANY ERRORS. PERFORMED LUNG-MAPPING TEST BUT COULD NOT REPLICATE THE ISSUE. ADDITIONALLY, MOVED THE CATHETER AGGRESSIVELY WHILE PERFORMING LUNG-MAPPING TEST AND CATHETER WAS STILL INTACT WITH FIM. ENGINEERING TEAM CONFIRMED THE FAIRLY EASY PULL OFF ON TWO DIFFERENT CATHETERS. OBSERVED A BIT OF PROTRUSION OF FIBER INNER SLEEVE (INTERFERENCE AT FIBER CONNECTION) OF ABOUT 0.75MM - LIKELY THE PROBLEM. AS A FIX, THE FIBER JUMPER ASSEMBLY WILL BE REPLACED TO ADDRESS THE REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED BY A SENIOR FAILURE ANALYSIS ENGINEER. LOGS ARE AVAILABLE FOR EN0011 ON (B)(6) 2022. LOGS INDICATE THAT THE SYSTEM DETECTED THAT THE CATHETER WAS NO LONGER PRESENT AND WENT INACTIVE DURING THE FIRST PROCEDURE ON (B)(6) 2022. THE CATHETER GOING INACTIVE IS CAPTURED UNDER INFORMATIONAL ADVISORY 23216 IN THE ERROR LOGS. PER THE WTN_TRACE LOGS, THE SYSTEM DISPLAYED A "CATHETER REMOVED, WHAT WOULD YOU LIKE TO DO?" TAKEOVER MESSAGE ON SCREEN TO USER, AND THE USER CHOSE TO CONTINUE PROCEDURE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, AFTER THREE PASSES WITH THE NEEDLE, THE CATHETER POPPED OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, AFTER THREE PASSES WITH THE NEEDLE, THE CATHETER POPPED OFF. THEY WERE PLANNING ON USING THE NEEDLE TO COLLECT MORE SAMPLES BUT ELECTED NOT TO. THE ENDOLUMINAL TERRITORY ASSOCIATE (ETA) WAS NOT SURE IF THEY COLLECTED ADDITIONAL SAMPLES AS SHE WAS NOT ON SITE. IT WAS REPORTED THAT THE ION PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) MADE THE REQUIRED FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014511 ION SYSTEM CART EOQ INTUITIVE SURGICAL, INC 380748-55 N/A 00886874116234

    Patients

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