BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 7339769 · Received March 14, 2018

    Report

    Report Number
    2955842-2018-10070
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 27, 2018
    Report Date
    February 27, 2018
    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 SURGICAL, INC. (ISI) RECEIVED THE CURVED CANNULA ASSOCIATED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE CANNULA WAS FOUND TO HAVE A WELD DEFECT. 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 #428071-03 TO BE REPLACED AND RETURNED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE 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 SURGICAL PROCEDURE, THE CURVED CANNULA PULLED APART FROM WHERE IT LOCKS ONTO THE ROBOT. THE CANNULA WELD WAS REPORTED BROKEN. THERE WAS NO REPORT OF FRAGMENTS FALLING INSIDE THE PATIENT, PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181708 SINGLE-SITE CURVED CANNULA ARM1 NAY INTUITIVE SURGICAL, INC 428071-03 VE121608

    Patients

    Seq Age Sex Outcome Treatment
    1