BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CLIP APPLIER INSTRUMENT

    MDR report key: 3250586 · Received July 26, 2013

    Report

    Report Number
    2955842-2013-02774
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 14, 2013
    Report Date
    November 25, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THE REPORTED EVENT. FAILURE ANALYSIS INVESTIGATIONS OBSERVED A BROKEN GRIP AND A BENT GRIP AT THE INSTRUMENT'S TIP. THESE FAILURES WERE RELATED BECAUSE THE LIKELY CAUSE OF THE BREAKAGE OF THE GRIP-TIP WAS BENDING AT THE INSTRUMENT'S TIPS. THE PIECE THAT BROKE OFF THE GRIP-TIP WAS NOT RETURNED WITH THE INSTRUMENT. NO OTHER DAMAGE FOUND. EVIDENCE NOT CONCLUSIVE, BUT THE GRIP/TIP DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. THE INSTRUMENTS & ACCESSORIES INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES, HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE USER FACILITY IDENTIFIED A BROKEN TIP ON THE SMALL CLIP APPLIER INSTRUMENT. THE INSTRUMENT WAS NOT USED ON A PATIENT AFTER THE REPORTED ISSUE WAS IDENTIFIED AND THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349747 SMALL CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420003-06 S10120430 437

    Patients

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