BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3050445 · Received April 10, 2013

    Report

    Report Number
    2955842-2013-01177
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THAT THE INSTRUMENT'S HOUSING (2 OF THE 4 HOUSING SNAP TABS AND 3 OF THE ADJACENT HOUSING PINS) WERE BROKEN. THE INSTRUMENT'S HOUSING COULD BE REMOVED AS A RESULT OF THE DAMAGE. THE INSTRUMENT WAS ALSO MISSING ONE OF THE RELEASE LEVERS. THE INSTRUMENT'S HOUSING MOST LIKELY POPPED OFF DURING MISHANDLING, CAUSING RELEASE LEVERS TO FALL OUT. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE INSTRUMENT AND PASSED. ADDITIONAL FINDINGS NOT REPORTED BY THE SITE WERE DAMAGES TO THE LUER PLATE AND THE BIPOLAR PIN. ENGINEERING FOUND THAT THE LUER PLATE WAS DISLODGED FROM THE CHASSIS AND STICKING OUT PAST THE CHASSIS BACK PUSHED INTO THE BACKEND. A SECTION OF THE CHASSIS WALL FEATURE THAT HOLDS THE LUER PLATE WAS BROKEN OFF. ADDITIONAL FINDING WAS A BENT POLAR PIN. THE TOP BIPOLAR PIN WAS PUSHED DOWN TO THE BOTTOM PIN. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS MAIN TUBE DAMAGE. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND HAD A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT AXIALLY ALIGNED WITH THE TUBE. EVIDENCE NOT CONCLUSIVE, BUT ALL OF THE DAMAGES TO THE INSTRUMENT'S HOUSING, LUER PLATE, BIPOLAR PIN AND MAIN TUBE SUGGESTS MISHANDLING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR 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 RELEASE LEVERS ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT'S HOUSING WERE BROKEN. THE INSTRUMENT WAS NOT USED ON A PATIENT AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153455 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-06 M10091130 911

    Patients

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