BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3803061 · Received May 9, 2014

    Report

    Report Number
    2955842-2014-02893
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    December 19, 2013
    Report Date
    April 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT BOTH PITCH CABLES WERE FOUND TO BE BROKEN AT THE WRIST. BOTH CABLE SEGMENTS THAT CONTAINS THE CRIMP WERE STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI PROSTATECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE PK DISSECTING FORCEPS INSTRUMENT WIRE WAS BROKEN. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281584 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10130627 585

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR