BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CLIP APPLIER INSTRUMENT

    MDR report key: 2930201 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00295
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 29, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE COMPLAINT THAT THE ENDS OF THE INSTRUMENT BROKE OFF WAS CONFIRMED. BOTH CLIP APPLIER GRIPS WERE BROKEN AT THE MIDPOINT. EVIDENCE IS NOT CONCLUSIVE; HOWEVER, THE DAMAGE WAS LIKELY DUE TO EXCESS FORCE APPLIED NORMAL TO THE GRIP WHILE TRYING TO INSTALL A CLIP. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. 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 THYMECTOMY PROCEDURE, THE SURGICAL STAFF REPORTED, THAT BETWEEN LOADS WHILE THE INSTRUMENT WAS NOT IN THE PATIENT, THE ENDS OF THE SMALL CLIP APPLIER INSTRUMENT BROKE OFF. 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
    35800 SMALL CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420003-05 S10100105 585

    Patients

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