BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE 5 X 300 MM CURVEDCANNULA, ARM 2

    MDR report key: 5312287 · Received December 18, 2015

    Report

    Report Number
    2955842-2015-01502
    Event Type
    Malfunction
    Date Received
    December 18, 2015
    Date of Event
    November 25, 2015
    Report Date
    November 25, 2015
    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
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ACCESSORY WILL NOT BE RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CURVED CANNULA INSTRUMENT ACCESSORY TWISTS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE SINGLE SITE CURVED CANNULA SEEMED TO BE CURVED IN THE OPPOSITE DIRECTION. THE SINGLE SITE CURVED CANNULA ACCESSORY HAD BEEN USED FOR OVER TWO YEARS. THERE WAS NO ALLEGATION THAT ANY FRAGMENT(S) FROM THE ACCESSORY FELL INTO A PATIENT AND/OR THAT ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY OCCURRED INVOLVING THE REPORTED EVENT. ON DECEMBER 16, 2015, INTUITIVE SURGICAL INC., (ISI) CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION. THE CUSTOMER STATED THAT THE TOP PART OF THE SINGLE SITE CURVED CANNULA ACCESSORY TWISTS AT THE BOWL TO TUBE INTERFACE WHERE IT SHOULD BE STATIONARY. THE CUSTOMER INDICATED THAT THE ITEM WILL NOT BE RETURNED TO ISI FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837833 SINGLE-SITE 5 X 300 MM CURVEDCANNULA, ARM 2 ENDOSCOPIC ACCESSORY NAY INTUITIVE SURGICAL,INC. 428062-03

    Patients

    Seq Age Sex Outcome Treatment
    1