BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 4142045 · Received October 4, 2014

    Report

    Report Number
    1219930-2014-00917
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC SIGMOID ACCORDING TO THE REPORTER: THE INSTRUMENT DID NOT FIRE DURING 3 DIFFERENT PROCEDURES WITH 3 DIFFERENT SURGEONS (ALWAYS SAME IDRIVE WITH SAME ADAPTER). NO PATIENT HARM. NO PATIENT INJURED, NO EXTENSION OF INCISION OR SURGERY TIME, NO BLOOD LOSS, NO TISSUE DAMAGE, NO CHANGE OF PROCEDURE, NO PART FELL INTO CAVITY, NO REINFORCEMENT MATERIAL USED. ADDITIONAL INFORMATION 1. PLEASE CONFIRM THAT PRODUCT WILL BE RETURNED FOR INVESTIGATION. YES 2. DID ALL PROCEDURES OCCUR ON THE SAME DATE? YES 3. DID THE DEVICE FUNCTION PROPERLY AFTER THE INITIAL MALFUNCTION? NO, A SINGLE USE HANDLE WAS USED A) IF NOT, WHAT WAS THE DONE TO COMPLETE THE PROCEDURE? 4. WHAT ARE THE STATUS LIGHTS DISPLAYING ON THE I-DRIVE? ALL LIGHTS ARE GREEN, AFTER PRESS THE FIRE BUTTON NOTHING HAPPENED 5. WHAT IS THE PRODUCT ID AND LOT NUMBER FOR THE RELOAD USED WITH THIS STAPLER? IF THE CUSTOMER CANNOT SUPPLY THE PRODUCT ID OR LOT NUMBER, WAS THE RELOAD A UNIVERSAL ROTICULATOR SULU, A STRAIGHT SULU, OR A TRI-STAPLE RELOAD? TRI-STAPLE RELOAD 6. WHAT IS THE PATIENT AGE, WEIGHT, GENDER? (B)(6), FEMALE 7. WHAT IS THE LAST KNOWN PATIENT STATUS? PATIENT IS FINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621701 IDRIVE ULTRA POWERED HANDLE 1 REUSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON IDRVULTRA1 N4D1306UX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR EGIAADAPT, ENDO GIA ADAPTER STANDARD,