BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3970901 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04633
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE PITCH CABLE WAS DERAILED FROM THE BACK IDLER PULLEYS, RESULTING IN NON-INTUITIVE MOTION OF THE INSTRUMENT. THE CABLE WAS WEDGED BETWEEN TWO PULLEYS AND HAD LOST TENSION, BUT THE CLAMPING PULLEY SCREWS WERE STILL TIGHT. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE PITCH UP CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE INTACT AND UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE FOUND DURING FAILURE ANALYSIS INVESTIGATION, 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 DURING A DA VINCI PROSTATECTOMY PROCEDURE, ONE WRIST CABLE LOST TENSION ON THE PK DISSECTING FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447749 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10131213 642

    Patients

    Seq Age Sex Outcome Treatment
    1