BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2970755 · Received February 20, 2013

    Report

    Report Number
    2955842-2013-00570
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 24, 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 PITCH CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINED THE CRIMP, HAD ONE CRIMP MISSING. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS THAT HAD LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH. THE SCRATCHES WERE SHORT IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE TO MISUSE/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. 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 REPORTED THAT AFTER SUCCESSFUL COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BECAME STUCK INSIDE OF THE PORT DURING REMOVAL OF THE INSTRUMENT FROM THE PATIENT. AFTER THE INSTRUMENT WAS REMOVED, INSPECTION OF THE INSTRUMENT BY THE OR NURSE FOUND THAT ONE WIRE AT THE DISTAL TIP OF THE INSTRUMENT WAS BROKEN. NO MISSING OR FALLEN PIECES WERE REPORTED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74115 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10120426 332

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR DA VINCI SI SUGICAL SYSTEM, ACCESSORIES AND ESU.