BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17826077 · Received September 27, 2023

    Report

    Report Number
    2955842-2023-18747
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    August 28, 2023
    Report Date
    August 30, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA - UNILATERAL SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT THREADS WERE GETTING CAUGHT ON SOME TISSUE DOWN BY THE INSTRUMENT HEAD. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED WITH A BACKUP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TARGET TISSUE WAS THE MOMENTUM AND SOME BOWEL. DISSECTION OF THE TISSUE WAS BEING PERFORMED AT THE TIME OF THE EVENT IN PREPARATION OF A HERNIA MESH PLACEMENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS IN USE APPROXIMATELY 5-10 MINUTES PRIOR TO THE REPORTED EVENT. THE TISSUE WAS STUCK TO THE THREAD STICKING OUT FROM THE PULLEY. THE TISSUE WAS RELEASED WITH MINOR MOVEMENT OF THE INSTRUMENT. NOTHING HAD TO BE FORCEFULLY REMOVED. THERE WAS NOT ANY TISSUE EXCISED DUE TO THE EVENT. THERE WAS NO BLEEDING DUE TO THE EVENT. THERE WAS MINIMAL IMPACT ON SURGICAL TIME. THE CUSTOMER ONLY HAD TO PULL AND REPLACE THE INSTRUMENT. THE EVENT DID NOT AFFECT THE PATIENT¿S HEALTH. THERE IS NO CONCERN ABOUT THIS EVENT CAUSING ANY LONG-TERM COMPLICATIONS WITH THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT¿S CURRENT STATUS IS UNREMARKABLE POST-OPERATIVE APPOINTMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020072 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K12230526 0261 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES