BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3192746 · Received June 27, 2013

    Report

    Report Number
    2955842-2013-02323
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING CONFIRMED THERE WAS A BROKEN PITCH CABLE AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT EXCESSIVE DAMAGE OR WEAR MARKS. 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

    IT WAS REPORTED THAT DURING A DA VINCI SI PROCEDURE, THE CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BROKE. 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
    292824 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10121018 510

    Patients

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