BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3964782 · Received July 29, 2014

    Report

    Report Number
    2955842-2014-04594
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 2, 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 Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI HYSTERECTOMY PROCEDURE THAT THE PK DISSECTING FORCEPS INSTRUMENT'S CABLE BROKE/SNAPPED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441732 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10130826 718

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR