BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE CURVED CANNULA INSRUMENT ACCESSORY

    MDR report key: 3844111 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03385
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Removal / Correction Number
    2955842-02-28-2014-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SINGLE SITE CURVED CANNULA ACCESSORY WAS RETURNED AND EVALUATED. THE CANNULA WAS PLACED ON AN IN-HOUSE SYSTEM AND INSTRUMENTS MET RESISTANCE WHEN ATTEMPTING TO ADVANCE THROUGH THE CANNULA AND THE INSTRUMENT HEATSHRINK WAS SCRATCHED WHEN PASSED THROUGH THE CANNULA. FAILURE ANALYSIS INVESTIGATION ALSO FOUND A WELD DEFECT AT THE TUBE AND BOWL INTERFACE. THE WELD WAS CRACKED AROUND THE CIRCUMFERENCE OF THE TUBE. AS A RESULT, THE TUBE ROTATED FREELY. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE DAMAGE TO THE WELD, FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOT ABLE TO ADVANCE THROUGH THE SINGLE SITE CURVED CANNULA ACCESSORY. THE INSTRUMENT MET RESISTANCE, BUT OTHER INSTRUMENTS WERE ABLE TO ADVANCE THROUGH IT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE 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
    321996 SINGLE-SITE CURVED CANNULA INSRUMENT ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 428071-03 VE121407

    Patients

    Seq Age Sex Outcome Treatment
    1