BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA

    MDR report key: 6836171 · Received August 31, 2017

    Report

    Report Number
    1219930-2017-06853
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 4, 2017
    Report Date
    September 8, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 2035-10-31, SERIAL#: (B)(4), (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC TOTAL GASTRECTOMY PROCEDURE. FOR THE FOURTH FIRING FOR THE FUNCTIONAL SIDE TO SIDE ANASTOMOSIS OF THE JEJUNUM, THE SURGEON TRIED TO CLAMP THE TISSUE. HOWEVER, COULD NOT FULLY CLOSE THE JAWS AND COULD NOT FIRE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AS PER THE ADDITIONAL INFORMATION RECEIVED, NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613549 IDRIVE ULTRA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN IDRVULTRA1

    Patients

    Seq Age Sex Outcome Treatment
    1