BEUDAMED
    FDA Adverse Event Other Summary report: N

    M/L-10 CLIP APPLIER

    MDR report key: 2976608 · Received February 20, 2013

    Report

    Report Number
    1223422-2012-00007
    Event Type
    Other
    Date Received
    February 20, 2013
    Report Date
    February 20, 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 M/L-10 CLIP APPLIER WAS RETURNED, DECONTAMINATED AND INVESTIGATED. THE RETURNED CLIP APPLIER WAS RECEIVED WITH THE OUTER TUBE IN PLACE, THE TRIGGER WAS IN THE HOME POSITION, AND WITHOUT A CLIP CARTRIDGE. THE CLIP APPLIER APPEARED TO BE IN GOOD VISUAL CONDITION AND THE TRIGGER OPERATED FREELY. THE JAWS WERE MEASURED AND FOUND TO BE OUT OF SPECIFICATION. A CLIP CARTRIDGE WAS CYCLED WITHOUT INCIDENT. THE JAW DAMAGE FOUND IS CONSISTENT WITH MISHANDLING, HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING SURGERY, THE CLIP APPLIER WAS USED TO PLACE CLIPS IN ORDER OR CLAMP OFF THE CYSTIC DUCT. THE JAWS OF THE CLIP APPLIER CAUSED A LACERATION OF THE CYSTIC DUCT CAUSING AN UNDETECTED MICRO-LESION. A SECOND SURGERY WAS NEEDED TO CORRECT THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75055 M/L-10 CLIP APPLIER CLIP APPLIER GCJ MICROLINE SURGICAL INC. 1002 00103676

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization