BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACK DIAMOND MICRO FORCEPS INSTRUMENT

    MDR report key: 2981173 · Received February 27, 2013

    Report

    Report Number
    2955842-2013-00655
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE ONE TIP WAS BENT CLOSE TO THE TIP AREA. THE GRIPS SHOULD BE STRAIGHT AGAINST THE OTHER TIP. ENGINEERING CONCLUDED THAT DAMAGE TO THE TIPS WERE LIKELY DUE TO MISHANDLING. ENGINEERING ALSO FOUND INDENTATIONS ON THE EDGES OF THE PULLEY AND SOME SCRATCHES ON THE SURFACE OF THE PULLEY. THERE WERE ALSO VARIOUS SCRATCHES ON THE DISTAL END OF THE MAINTUBE SHOWING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT DAMAGE TO THE MAIN TUBE WAS LIKELY DUE TO MISHANDLING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE THE BLACK DIAMOND MICRO FORCEPS INSTRUMENT TIPS DID NOT ALIGN. 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
    83716 BLACK DIAMOND MICRO FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420033-05 S10100215 945

    Patients

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