BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRRUMENT

    MDR report key: 3083264 · Received April 29, 2013

    Report

    Report Number
    2955842-2013-01441
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 27, 2011
    Report Date
    April 25, 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. ENGINEERING EVALUATION DID NOT CONFIRM THE ALLEGED COMPLAINT. VISUAL INSPECTION OF THE INSTRUMENT SHOWED NO DAMAGE TO THE CONDUCTOR WIRES. THE INSTRUMENT WAS CHECKED FOR ELECTRICAL CONTINUITY, WHICH IS AN INDICATOR OF CAUTERY FUNCTION. THE ELECTRICAL CONTINUITY TEST PASSED. FUNCTIONAL CAUTERY TEST USING A BIPOLAR CORD AND GENERATOR WAS PERFORMED AND THE INSTRUMENT SUCCESSFULLY TRANSFERRED ENERGY TO A WET PAPER TOWEL, CAUSING STEAM TO BE GENERATED. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WERE DAMAGES TO THE BIPOLAR PINS AND MAIN TUBE. BOTH BIPOLAR PINS WERE BENT SIDEWAYS. THE BOTTOM PIN WAS BENT MORE THAN THE TOP PIN. A BIPOLAR CORD CAN STILL BE INSTALLED BUT IT WILL NOT SEAT FLUSH AGAINST THE CHASSIS. ENGINEERING EVALUATION NOTED THAT THE DISTAL END OF THE INSTRUMENT'S MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AND HAD A ROUGH SURFACE FINISH. SCRATCHES WERE 0.065 - 0.100 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT THE DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. 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

    DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE BIPOLAR ENERGY OF THE MONOPOLAR CURVED SCISSORS INSTRUMENT REPORTEDLY WAS NOT FUNCTIONING. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    184472 MARYLAND BIPOLAR FORCEPS INSTRRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10101109 920

    Patients

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