BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE

    MDR report key: 7526456 · Received May 18, 2018

    Report

    Report Number
    2955842-2018-10214
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 24, 2018
    Report Date
    April 24, 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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT 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 BOWEL. A FIELD SAFETY NOTICE #2955842-02-28-2014-001-R REQUESTED FOR ALL SINGLE-SITE 5MM CURVED CANNULA INCLUDING PART NUMBER 428071-03 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.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CURVED CANNULA ACCESSORY INVOLVED WITH THIS COMPLAINT, HOWEVER THE DEVICE EVALUATION IS STILL IN PROGRESS AND HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE DEVICE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IN RECEIVED. 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. 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 CURVED CANNULA ACCESSORY WAS ROTATING THE WRONG WAY. THE CUSTOMER REMOVED IT AND REPLACED IT WITH A BACKUP. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368244 SINGLE-SITE CURVED CANNULA ARM1 NAY INTUITIVE SURGICAL, INC 428071-03 VE121105

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES