BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3103837 · Received May 10, 2013

    Report

    Report Number
    2955842-2013-01598
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH DAMAGE INSULATION ON THE CONDUCTOR WIRE BY THE YAW PULLEY. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE WERE GRIP BENT AND INSULATION TUBE DAMAGE. THE GRIP BENT WAS CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A 0.102 OFFSET AT THE TIPS, INDICATING OVERLOADING AT THE TIP. THE DISTAL END OF THE MAIN TUBE ALSO EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THESE DAMAGES WERE LIKELY DUE TO MISHANDLING. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE CONSOLE SURGEON NOTED DIFFICULTY WITH THE PATIENT SIDE MANIPULATOR (PSM) ARM MOVEMENTS OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT IN THE MIDDLE OF THE PROCEDURE. THE SCRUB NURSE REMOVED THE INSTRUMENT FOR INSPECTION AND FOUND THAT THE STRING OF THE INSTRUMENT WAS CUT. THE INSTRUMENT WAS REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206614 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10121127 421

    Patients

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