BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE PORT ACCESSORY

    MDR report key: 3801241 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02887
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE SINGLE-SITE PORT ACCESSORY WAS TORN ON ONE OF THE EDGES THAT GO INSIDE THE PATIENT. THERE MIGHT HAVE BEEN MATERIAL MISSING. NO OTHER DAMAGE WAS FOUND FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE FOUND. THE SINGLE SITE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: - USING AN ATRAUMATIC CLAMP LIKE A 9.25 (23.5 CM) CURVED MAYO-GUYON, GRASP AND CLAMP THE SINGLE-SITE PORT APPROXIMATELY 13 MM (~1/2) ABOVE ITS LOWER END, SO THAT IT IS FOLDED. MAKE SURE THE CURVE OF THE CLAMP IS ABOVE THE LOWER RIM OF THE FOLDED PORT, AND THAT THE INSUFFLATION ADAPTER BARB IS BETWEEN THE FOLDS OF PORT AND NOT CAUGHT IN THE CLAMP. - LUBRICATE THE LOWER PART OF THE PORT AND CLAMP BY WETTING IT WITH A STERILE SOLUTION (FOR EXAMPLE, SALINE OR STERILE WATER) THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE TEAR WITH MATERIAL MISSING FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE SINGLE-SITE PORT TORE DURING INSERTION AND IT WAS NOTED AFTER COMPLETION OF THE PROCEDURE. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278643 SINGLE-SITE PORT ACCESSORY ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428065-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1