BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3800921 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02871
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT AND COMPLETED DEVICE EVALUATION. INVESTIGATION CONFIRMED THE CUSTOMER'S REPORTED ISSUE. THE INSTRUMENT PITCH CABLES WERE BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DOES NOT EXHIBIT ANY WEAR. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGES WERE FOUND ON THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PK DISSECTING FORCEPS INSTRUMENT WIRE WAS BROKEN AND STICKING OUT AT THE END. NOTHING FELL INTO THE PATIENT AND THERE WAS NO REPORT OF PATIENT INJURY RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277979 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 N10140115 533

    Patients

    Seq Age Sex Outcome Treatment
    1