BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3943499 · Received July 18, 2014

    Report

    Report Number
    2955842-2014-04381
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S PITCH CABLE TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE INSTRUMENT'S DISTAL PULLEY HAD SCRATCH MARKS/ABRASIONS. THERE WERE SCRATCHES ON THE SURFACE OF THE DISTAL PULLEY. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, A BROKEN WIRE WAS IDENTIFIED ON THE PROGRASP FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422258 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10140228 811

    Patients

    Seq Age Sex Outcome Treatment
    1