BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS

    MDR report key: 6142619 · Received December 2, 2016

    Report

    Report Number
    2955842-2016-00859
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    April 10, 2016
    Report Date
    November 4, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K150284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT EXHIBITED A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN PITCH CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN PITCH CABLE, FOUND DURING FAILURE ANALYSIS EVALUATION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT TIP WAS NOT FUNCTIONING CORRECTLY. MORE SPECIFICALLY THE MOVEMENT OF THE TIPS OF THE INSTRUMENT WERE RESTRICTED. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792269 CADIERE FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 470049-04 S10160127 0032

    Patients

    Seq Age Sex Outcome Treatment
    1