BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 3000744 · Received March 12, 2013

    Report

    Report Number
    2955842-2013-00805
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AT THE DISTAL END OF THE MAIN TUBE. THE SCRATCHES WERE .080 - .190 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE TO THE MAIN TUBE WAS LIKELY DUE TO MISHANDLING. NO OTHER DAMAGE FOUND. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE INSTRUMENT WAS CHECKED FOR RECOGNITION ON AN IN-HOUSE IS3000 SYSTEM AND THE SYSTEM SUCCESSFULLY RECOGNIZED THE INSTRUMENT; IT SHOWED 0 USES LEFT AND DISPLAYED AN INSTRUMENT IS EXPIRED MESSAGE AS EXPECTED. THE POGO PINS DID NOT STICK AND WERE NOT CONTAMINATED. ENGINEERING WAS NOT ABLE TO REPLICATE THE RECOGNITION ISSUE. 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. O 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. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE THAT THE CADIERE FORCEPS INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. NO MISSING OR FALLEN PIECES WERE 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
    103292 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420049-06 M10110303 189

    Patients

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