BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPSINSTRUMENT

    MDR report key: 2964188 · Received February 15, 2013

    Report

    Report Number
    2955842-2013-00519
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING EVALUATION CONFIRMED THE ALLEGED COMPLAINT OF A BROKEN CABLE IN THE IN THE INSTRUMENT'S WRIST. THE PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS FOUND TO BE STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE INSTRUMENT'S WRIST WERE NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED BROKEN CABLE ISSUE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) PROCEDURE, THE SURGICAL STAFF ALLEGED THAT A BROKEN WIRE WAS OBSERVED IN THE WRIST OF THE PK DISSECTING FORCEPS INSTRUMENT . THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66931 PK DISSECTING FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10121122 784

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR DA VINCI SI SURGICAL SYSTEM AND ACCESSORIES