BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ML-10 MUTI-FIRE CLIP APPLIER

    MDR report key: 7013618 · Received November 9, 2017

    Report

    Report Number
    1223422-2017-00132
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    September 24, 2017
    Report Date
    December 20, 2017
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GCJ
    PMA / PMN Number
    K013695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. NO INVESTIGATION CAN BE PERFORMED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED, DECONTAMINATED AND VISUALLY INVESTIGATED. THERE WERE SIGNS OF PHYSICAL DAMAGES ON THE DEVICE. THE DEVICE WAS RETURNED WITH A BROKEN BAR FEEDER AND WITH A CLIP CARTRIDGE STILL STUCK IN THE CHAMBER. THESE ARE BOTH INDICATORS THAT THE DEVICE DID INDEED EXPERIENCE A MECHANICAL JAM. TO DETERMINE WHY THE DEVICE WOULD NOT OPERATE AS INTENDED, THE HAND-PIECE WAS OPENED AND ALL INTERNAL COMPONENTS WERE EXAMINED. THE CLIP FEED MECHANISM WAS UNRESPONSIVE AND WOULD NOT MOVE. THE FEEDER BAR WAS CUT AND THE CLIP PUSH MECHANISM MOVED FREELY ALLOWING FOR THE CLIP CARTRIDGE TO BE REMOVED FROM THE DEVICE. UPON REMOVAL OF THE CLIP CARTRIDGE 6 OPEN CLIPS FELL OUT OF THE DEVICE ALONG WITH 1 CRIMPED PIN. THIS IS A CLEAR INDICATION THAT THE DEVICE WAS FIRED INCORRECTLY, POSSIBLE IN THE UPWARD DIRECTION, WITH THE JAWS OF THE DEVICE POINTING UP. IF THE DEVICE IS FIRED THIS WAY, THE CLIP WILL FALL BACK INTO THE DEVICE, SO THAT WHEN THE NEXT CLIP IS FIRED THE DEVICE WILL EXPERIENCE A MECHANICAL JAM. THIS COMPLAINT IS CONFIRMED. A POSSIBLE ROOT CAUSE MAY HAVE BEEN DUE YOU THE DEVICE BEING ACTIVATED IN THE WRONG POSITION. REF: 1223422-2017-00132, 1223422-2017-00133, 1223422-2017-00134, 1223422-2017-00135.

    Description of Event or Problem · 1

    DURING A SURGICAL CHOLECYSTECTOMY, THE SURGEON ATTEMPTED TO FIRE A CLIPS AND EXPERIENCED A MECHANICAL JAM. THE PROCEDURE AND ANESTHESIA TIME WAS EXTENDED FOR 20 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794773 ML-10 MUTI-FIRE CLIP APPLIER CLIP IMPLANTABLE GCJ MICROLINE SURGICAL INC. 1002 00133658

    Patients

    Seq Age Sex Outcome Treatment
    1