BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPR-CLIP 12MM LPW

    MDR report key: 4330317 · Received December 15, 2014

    Report

    Report Number
    1219930-2014-01152
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDO
    PMA / PMN Number
    K925602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: PROSTATECTOMY. ACCORDING TO THE REPORTER: WHEN THE PA CLOSES THE CLIP AND TRIES TO PULL THE APPLIER OFF, IT STICKS AND WON'T RELEASE THE CLIP. ONE PULLED OFF AND TORE THE TISSUE, RESULTING IN BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820056 LAPR-CLIP 12MM LPW DISPOSABLE CLIP APPLIER GDO COVIDIEN, FORMERLY US SURGICAL A DIVISON 8886848812 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other