BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3078286 · Received April 25, 2013

    Report

    Report Number
    2955842-2013-01391
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 29, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THE ALLEGED COMPLAINT: THE BIPOLAR INSERT WAS DISLODGED FROM THE PLUG RISER AND WAS PARTIALLY STICKING OUT. THE BIPOLAR PINS WERE SLIGHTLY LOOSE DUE TO THE DISLODGED INSERT. THE INSERT MAY HAVE NOT BEEN FULLY SEATED IN THE CHASSIS OR MAY HAVE BEEN PULLED OUT WHEN THE BIPOLAR CORD WAS REMOVED. INSPECTION OF THE INSERT SHOWED THE RETENTION TABS PINCHED INWARDS, WHICH REDUCED THE ENGAGEMENT WITH THE PLUG RISER. ADDITIONAL OBSERVATION NOT INITIALLY REPORTED BY THE SITE WAS MAIN TUBE DAMAGE. THE DISTAL END OF THE MAIN TUBE EXHIBITED VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .060 - .120 IN LENGTH AND WERE NOT ALIGNED WITH THE MAIN TUBE AXIS. ENGINEERING CONCLUDED THAT THE MAIN TUBE 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 PROSTATECTOMY PROCEDURE, THE BIPOLAR PRONGS ALLEGEDLY CAME OUT OF THE MARYLAND BIPOLAR FORCEPS. 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
    177942 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 400172-08 M10121203 193

    Patients

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