BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3950907 · Received July 22, 2014

    Report

    Report Number
    2955842-2014-04481
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PITCH DOWN CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN SEGMENT WHICH CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE BROKEN PITCH CABLE WERE TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI COLECTOMY PROCEDURE THAT THE PROGRASP FORCEPS INSTRUMENT'S WIRE BROKE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429010 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131216 617

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR