BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE 5 X 300 MM CURVEDCANNULA, ARM 1

    MDR report key: 5250733 · Received November 25, 2015

    Report

    Report Number
    2955842-2015-01439
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 11, 2015
    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) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED FAILURE MODE. VISUAL INSPECTION FOUND A WELD DEFECT. THE TUBE SECTION THAT GOES IN THE BOWL WAS STILL INTACT. 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 CENTRAL PROCESSING, THE SINGLE-SITE CURVED CANNULA WAS FOUND TO BE BROKEN IN TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780658 SINGLE-SITE 5 X 300 MM CURVEDCANNULA, ARM 1 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428061-03 VE122606

    Patients

    Seq Age Sex Outcome Treatment
    1