BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 4203120 · Received October 27, 2014

    Report

    Report Number
    2955842-2014-05543
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC., (ISI) RECEIVED AND EVALUATED THE INSTRUMENT. INVESTIGATION REVEALED THAT THE PITCH CABLE WAS BROKEN AT THE PROXIMAL CLEVIS HUB. THE CLEVIS DID NOT EXHIBIT ANY WEAR. THE BROKEN STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE UNDAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN PITCH 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 WAS NOTED TO HAVE A FRAYED WIRE AT THE TIP OF THE INSTRUMENT DURING REPROCESSING. THERE WAS NO ALLEGATION THAT ANY FRAGMENT(S) FROM THE INSTRUMENT FELL INTO A PATIENT AND/OR THAT ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY OCCURRED INVOLVING THE REPORTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682866 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-05 N11140626 143

    Patients

    Seq Age Sex Outcome Treatment
    1