BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL CLIP APPLIER INSTRUMENT

    MDR report key: 3160471 · Received June 10, 2013

    Report

    Report Number
    2955842-2013-02086
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. RECEIVED THE INSTRUMENT INVOLVED WITH THE COMPLAINT. ENGINEERING CONFIRMED BOTH GRIPS ON THE INSTRUMENT WERE BROKEN: BROKEN PIECES WERE NOT RETURNED. THE GRIPS FRACTURED NEAR THE BASE OF THE CLIP GROOVE. ONE GRIP BROKE 0.035 ABOVE THE LOCATION OF THE OTHER GRIP. THE LONGER GRIP HAD A SLIGHT BEND BELOW THE FRACTURE SURFACE. NO OTHER DAMAGE FOUND. EVIDENCE NOT CONCLUSIVE, BUT GRIPS DAMAGE MAY BE DUE TO MISHANDLING/MISUSE. THE INSTRUMENTS & ACCESSORIES 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. 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 ESOPHAGECTOMY PROCEDURE, THE TIPS OF THE SMALL CLIP APPLIER INSTRUMENT BROKE WHEN THE SURGICAL STAFF ATTEMPTED TO INSERT A CLIP INTO THE INSTRUMENT . NO MISSING PIECES OR FALLEN PIECES REPORTED. THE REPORTED ISSUE OCCURRED OUTSIDE OF THE PATIENT'S BODY. 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
    260878 SMALL CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420003-06 S10120418 219

    Patients

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