BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2883637 · Received December 21, 2012

    Report

    Report Number
    2955842-2012-01402
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 27, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED ONE GRIP IS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE IS A .050 OFFSET AT THE TIPS. THE BENT GRIP HAS SEPARATION OF THE YAW PULLEY AND THE PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE ARE TUBE DAMAGE AND CORROSION ON THE CLAMPING PULLEYS. THE DISTAL END OF THE MAIN TUBE HAS A COUPLE GOUGES EXHIBITING MATERIAL REMOVAL. THE SCRATCHES ARE .110 - .120 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. THE TUBE SURFACE ALSO HAS AREAS THAT FEEL ROUGH THROUGHOUT THE LENGTH OF THE TUBE. THE HOUSING WAS REMOVED TO FIND THE CLAMPING PULLEYS EXHIBITING LIGHT PITTING CORROSION. THE EVIDENCE IS NOT CONCLUSIVE, BUT PITTING DAMAGE MAY BE DUE TO IMPROPER CLEANING. 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. 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 OBSERVED DURING CENTRAL PROCESSING THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TIPS WERE NOT ALIGNED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110518 189

    Patients

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