BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3028506 · Received April 1, 2013

    Report

    Report Number
    2955842-2013-01049
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE REPORTED COMPLAINT. THE GRASPING FUNCTIONALITY WAS REDUCED BY BENT GRIPS. BOTH GRIPS WERE BENT AND ONE WAS TWISTED SO THAT THERE WAS A .160 GAP AT THE TIPS WHEN GRIPS WERE IN THE CLOSED POSITION. THE BENT GRIPS HAD SEPARATION BETWEEN YAW PULLEY AND YAW PULLEY COVER, INDICATING OVERLOADING AT THE TIP. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .080 - .175 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. GRIP AND TUBE DAMAGE WAS LIKELY CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. 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 THAT DURING A DA VINCI SI COLECTOMY PROCEDURE THE FENESTRATED BIPOLAR FORCEPS WOULD NOT GRASP. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH A REPLACEMENT INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132946 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120717 405

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM ESU INSTRUMENTS ACCESSORIES