BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXISION

    MDR report key: 15921350 · Received December 5, 2022

    Report

    Report Number
    2955842-2022-15744
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 7, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    EOQ
    UDI-DI
    10886874115968
    PMA / PMN Number
    K182188
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE FAILED TO ADVANCE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BIOPSY NEEDLE INSTRUMENT WAS ANALYZED AND THE NEEDLE DID NOT FULLY EXTEND OUT WHEN ACTUATED WITH THE NEEDLE HANDLE AT VARIOUS INSERTION DEPTHS. THE DISTAL END DID NOT APPEAR TO HAVE ANY PIERCINGS OR PUNCTURES. THERE WAS HIGH FRICTION BETWEEN THE SHEATH AND NEEDLE SHAFT WHEN TRYING TO EXTEND THE NEEDLE USING THE NEEDLE HANDLE. THE COMPLAINT REGARDING THE BIOPSY NEEDLE FAILED TO ADVANCE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. VERIFICATION OF THE EVENT DETAILS CANNOT BE PERFORMED VIA SYSTEM LOGS BECAUSE SYSTEM LOGS DO NOT EXIST (ION SYSTEMS DO NOT HAVE ONSITE CONNECTIVITY AT THIS TIME). THIS COMPLAINT IS REPORTABLE MALFUNCTION AND ADVERSE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE BIOPSY NEEDLE FAILED TO ADVANCE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. IT IS UNKNOWN IF A FRAGMENT WAS RETRIEVED OR NOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE FAILED TO ADVANCE. THE DIAGNOSTIC PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE 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
    1959919 FLEXISION BIOPSY NEEDLE, 21G EOQ INTUITIVE SURGICAL, INC 490103-10 L210049 10886874115968

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ION ENDOLUMINAL SYSTEM