BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CLIP APPLIER

    MDR report key: 2830773 · Received November 13, 2012

    Report

    Report Number
    2955842-2012-00909
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 12, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE SIDE OF THE CLIP APPLIER WAS FOUND TO BE BROKEN AND THE OTHER SIDE WAS BENT AT THE MIDPOINT SECTION. THE GRIPS SHOULD HAVE BEEN STRAIGHT, BUT THEY HAD A BEND ANGLE OF ROUGHLY 30 DEGREES. THE BREAKING AND BENDING WAS LIKELY DUE TO APPLYING FORCE TO THE GRIP WHILE TRYING TO INSTALL THE CLIP. THE CLIP APPLIER MISSING PART WAS NOT RETURNED WITH THE INSTRUMENT. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DAVINCI SI SURGICAL PROCEDURE, WHILE THE CUSTOMER TRIED TO LOAD THE CLIP ON THE SMALL CLIP APPLIER INSTRUMENT, THE TIP BENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL CLIP APPLIER ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420003-06 S10110518 982

    Patients

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