BEUDAMED
    FDA Adverse Event Summary report: N

    MARYLAND BIPOLAR FORCEPS

    MDR report key: 2895864 · Received January 3, 2013

    Report

    Report Number
    2955842-2013-00046
    Date Received
    January 3, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 5, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ELECTRICAL CONTINUITY FAILED. THERE WAS A BROKEN CONDUCTOR WIRE AT THE YAW PULLEY EXIT. THE WIRE IS DETACHED FROM ITS CONNECTION AT THE GRIP. THE YAW PULLEY SHOWS NO SIGNS OF ARCING. THE INSTRUMENT HAS 5 USES REMAINING. 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 PRIOR TO STARTING A DA VINCI S SURGICAL PROCEDURE, A LOOSE WIRE WAS NOTED ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. REPORTEDLY, THE INSTRUMENT WAS ALSO NOT READING LIVES WHEN PLUGGED IN. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340 MARYLAND BIPOLAR FORCEPS ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110301 148

    Patients

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