BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE 5 X 250 MM CURVEDCANNULA,ARM 2

    MDR report key: 5251148 · Received November 25, 2015

    Report

    Report Number
    2955842-2015-01447
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CANNULA HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 A DA VINCI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE CUSTOMER IDENTIFIED AN ISSUE WITH A SINGLE SITE CURVED CANNULA. THE CUSTOMER STATED THAT THE BOWL WAS TWISTING OFF. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781690 SINGLE-SITE 5 X 250 MM CURVEDCANNULA,ARM 2 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428072-03 VE120603

    Patients

    Seq Age Sex Outcome Treatment
    1