BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 3003002 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00827
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION RESULTS CONFIRMED THE ALLEGED ISSUE THAT THE INSTRUMENT WOULD NOT DOCK PROPERLY BECAUSE OF A BENT PRONG. THE UPPER LEFT PIN ON THE 5 PIN PK CONNECTOR WAS FOUND TO BE BENT DOWNWARDS. A PK CORD COULD NOT BE PROPERLY INSTALLED DUE TO THE BENT PIN. ELECTRICAL CONTINUITY TESTING OF THE INSTRUMENT PASSED. ENGINEERING EVALUATION ALSO FOUND TUBE DAMAGE. THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .070 - .080 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING EVALUATION CONCLUDED THAT THE SCRATCHES WERE LIKELY DUE TO MISHANDLING/MISUSE. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS O 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. INTUITIVE SURGICAL HAS ATTEMPTED TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MAIN TUBE SCRATCH ISSUE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF ALLEGEDLY NOTICED THAT THE PK DISSECTING FORCEPS INSTRUMENT WOULD NOT DOCK BECAUSE OF A BENT PRONG. 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
    106116 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10121123 972

    Patients

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