BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE 5 X 250 MM CURVEDCANNULA,ARM 2

    MDR report key: 6919349 · Received October 5, 2017

    Report

    Report Number
    2955842-2017-00664
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICIAL, INC. (ISI) HAS NOT RECEIVED THE SINGLE-SITE 5MM CURVED CANNULA FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION AND/OR THE ACCESSORY IS RETURNED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. 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 5MM 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 PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TUBE WELDED ONTO THE SINGLE-SITE 5MM CURVED CANNULA ACCESSORY WAS BROKEN. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695309 SINGLE-SITE 5 X 250 MM CURVEDCANNULA,ARM 2 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428072-03 VE121609

    Patients

    Seq Age Sex Outcome Treatment
    1