BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3972860 · Received August 1, 2014

    Report

    Report Number
    2955842-2014-04657
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THE INSTRUMENT'S PITCH CABLE TO BE FRAYED AT THE DISTAL IDLER. THERE WAS NO DAMAGE FOUND ON THE CLEVIS. 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 FRAYED 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 CABLE WAS IDENTIFIED ON THE PK DISSECTING 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
    450947 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10140227 427

    Patients

    Seq Age Sex Outcome Treatment
    1