BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ADAPTER STANDARD

    MDR report key: 3932170 · Received April 3, 2014

    Report

    Report Number
    1219930-2014-00276
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 13, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LADG. ACCORDING TO THE REPORTER: PRIOR TO USE THE JAW COULD NOT OPEN AND CLOSE SMOOTHLY. THE JAWS COULD BE OPENED WHEN THE OPEN BUTTON WAS PRESSED, AND THE JAWS COULD BE CLOSED WHEN THE CLOSE BUTTON WAS PRESSED. THE JAWS FAILED TO OPEN AND CLOSE COMPLETELY. OPENED ANOTHER INSTRUMENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT. OPERATING TIME WAS NOT EXTENDED. UNKNOWN USE OF REINFORCEMENT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200352 ENDO GIA ADAPTER STANDARD REUSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES

    Patients

    Seq Age Sex Outcome Treatment
    1