BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART

    MDR report key: 6725219 · Received July 19, 2017

    Report

    Report Number
    1223422-2017-00111
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 22, 2017
    Report Date
    October 31, 2017
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, AND VISUALLY INVESTIGATED. THERE WERE NO SIGNS OF PHYSICAL DAMAGES OR WEAR AND TEAR TO THE CLIP CARTRIDGES AND ITS PACKAGING. FOR FUNCTIONAL TESTING, A CLIP CARTRIDGE WAS INSERTED INTO A WORKING CLIP APPLIER. ALL TEN CLIPS WERE RELEASED CRIMPED AND CLOSED AS THE TRIGGER FROM THE CLIP APPLIER WAS SQUEEZED. NO COMPLICATIONS, HESITATIONS OR JAMMING WAS OBSERVED. THIS PROCESS WAS REPEATED 5 TIMES. STILL NO DEFECT WAS DETECTED. THIS COMPLAINT IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION IS NOT POSSIBLE AT THE MOMENT. THE CLIP CARTRIDGE WAS NOT RETURNED TO MICROLINE INC.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYTECTOMY SURGICAL PROCEDURE CLIPS FROM THE M/L-10 CLIP CARTRIDGE BEGAN TO LOCK ON DUCT AND WOULD NOT RELEASE FROM THE ML-10 CLIP APPLIER. SURGEON HAD TO FORCE THE APPLIER OFF THE CLIP ATTACHED TO THE DUCT . NO PATIENT DAMAGE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505594 DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART CLIP IMPLANTABLE GCJ MICROLINE SURGICAL, INC. 1122 00131976

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention