BEUDAMED
    FDA Adverse Event Other Summary report: N

    M/L-10 CLIP APPLIER HANDPIECES REUSABLE

    MDR report key: 3032577 · Received March 29, 2013

    Report

    Report Number
    1223422-2013-00011
    Event Type
    Other
    Date Received
    March 29, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE REF 1002 M/L-10 CLIP APPLIER WAS RETURNED, DECONTAMINATED AND INVESTIGATED. THE RETURNED CLIP APPLIER WAS RECEIVED WITH THE JAWS APART AND TRIGGER IN THE HOME POSITION. THE TRIGGER OPERATED FREELY AND THE DEVICE APPEARED TO BE IN GOOD MECHANICAL CONDITION. THE JAWS WERE MEASURED AND FOUND TO OUT OF SPECIFICATION. THE DAMAGED FOUND IS CONSISTENT WITH MISHANDLING. ALTHOUGH DAMAGE WAS FOUND, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    LOOSE CLIPS WERE FOUND NOT CLOSED IN THE ABDOMEN OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130356 M/L-10 CLIP APPLIER HANDPIECES REUSABLE M/L-10 CLIP APPLIER GCJ MICROLINE SURGICAL INC. 1002 00105133

    Patients

    Seq Age Sex Outcome Treatment
    1