BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROLINE REUSABLE LAPAROSCOPIC CLIP APPLIER

    MDR report key: 3844629 · Received May 7, 2014

    Report

    Report Number
    1223422-2014-00009
    Event Type
    Other
    Date Received
    May 7, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, A MECHANICAL JAM OCCUR CAUSING THE DEVICE TO MISFIRE. THE PHYSICIAN ATTEMPTED TO LIGATE THE CYSTIC DUST BUT THE CLIP DID NOT ADVANCE PROPERLY, RESULTING IN THE JAW OF THE CLIP APPLIER CUTTING INTO THE CYSTIC DUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276095 MICROLINE REUSABLE LAPAROSCOPIC CLIP APPLIER IMPLANTABLE CLIP GCJ MICROLINE SURGICAL INC. 1002R 57594R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other