BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3864246 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03558
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THAT THE PITCH CABLE WAS FRAYED AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE DAMAGED CABLE, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PK DISSECTING FORCEPS INSTRUMENT WOULD NOT RESPOND TO THE SURGEON'S MOVEMENTS IN THE CONSOLE DURING A DA VINCI HYSTERECTOMY PROCEDURE. SEVERAL TROUBLESHOOTING MANEUVERS WERE DONE INCLUDING RESEATING THE INSTRUMENT AND THE CASSETTE DRAPE TO THE INSTRUMENT ARM. A BACKUP INSTRUMENT HAD TO BE OPENED AND THE PLANNED PROCEDURE WAS COMPLETED. NO FRAGMENTS FELL INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338547 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10131209 950

    Patients

    Seq Age Sex Outcome Treatment
    1