BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE 5 X 300 MM CURVEDCANNULA, ARM 1

    MDR report key: 5478220 · Received March 3, 2016

    Report

    Report Number
    2955842-2016-00131
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 9, 2016
    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
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CANNULA INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED FAILURE MODE. THE CANNULA FOUND TO EXHIBIT A WELD DEFECT. WHEN COMPARED TO AN IN-HOUSE CANNULA SAMPLE, THE SHAFTS WERE FOUND TO POINT IN DIFFERENT DIRECTIONS SHOWING THAT THE CANNULA SHAFT HAD TWISTED. IN MAY 2014, FIELD SAFETY NOTICE 2955842-02-28-2014-001-R WAS DELIVERED TO THE SITE AND ACKNOWLEDGED. THE FIELD SAFETY NOTICE REQUESTED FOR ALL SINGLE-SITE 5MM CURVED CANNULAE INCLUDING PART 428072-03 TO BE REPLACED AND RETURNED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SINGLE SITE CURVED CANNULA HAS A POTENTIAL WELD DEFECT THAT COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE SINGLE-SITE CURVED CANNULA ACCESSORY WAS TWISTED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135075 SINGLE-SITE 5 X 300 MM CURVEDCANNULA, ARM 1 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428061-03 VE121403

    Patients

    Seq Age Sex Outcome Treatment
    1