BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK MEDIUM-LARGE CLIP APPLIER INSTRUMENT

    MDR report key: 3050041 · Received April 10, 2013

    Report

    Report Number
    2955842-2013-01173
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THE INSTRUMENT WAS NOT CLOSING. ENGINEERING FOUND THE WELDING CONNECTION OF THE WIRE WAS BROKEN OFF BY THE GRIP AREA RESULTING IN THE INSTRUMENT NOT BEING ABLE TO CLOSE. 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 DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE THE SINGLE SITE HEM-O-LOK MEDIUM LARGE CLIP APPLIER INSTRUMENT WOULD NOT CLOSE. THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. 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
    149360 HEM-O-LOK MEDIUM-LARGE CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428053-12 S10120730 646

    Patients

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