BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 7501319 · Received May 9, 2018

    Report

    Report Number
    2955842-2018-10195
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 16, 2018
    Report Date
    April 16, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THE COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE MODE. THE SINGLE SITE CURVED CANNULA WAS FOUND TO HAVE A WELD DEFECT. AS A RESULT THE SHAFT ROTATES FROM THE BOWL. A FIELD SAFETY NOTICE #2955842-02-28-2014-001-R REQUESTED FOR ALL SINGLE-SITE 5MM CURVED CANNULA INCLUDING PART NUMBER 428072-03 TO BE REPLACED AND RETURNED. THE 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 SURGICAL PROCEDURE, THE SINGLE SITE CURVED CANNULA WAS OBSERVED TO BE CURVING THE WRONG WAY. 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
    343824 SINGLE-SITE CURVED CANNULA ARM2 NAY INTUITIVE SURGICAL, INC 428072-03 VE122706

    Patients

    Seq Age Sex Outcome Treatment
    1