BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART

    MDR report key: 7013598 · Received November 9, 2017

    Report

    Report Number
    1223422-2017-00134
    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

    THREE DEVICES WERE RETURNED AND VISUALLY INSPECTED. ONE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING UNOPENED. (B)(4) THE SECOND DEVICE WAS RETURNED STUCK INSIDE A RETURNED HAND PIECE (B)(4). THE CLIP CARTRIDGE WAS DAMAGED AND IMPOSSIBLE TO REMOVE FROM THE DEVICE. BECAUSE OF THE CONDITION OF THE RETURNED CARTRIDGE A THOROUGH PRODUCT INVESTIGATION OF THE CARTRIDGE WAS NOT POSSIBLE. THE CARTRIDGE WAS LODGED INTO THE CLIP APPLIER, AND IMPOSSIBLE TO REMOVE. THEREFORE A FUNCTIONAL EXAMINATION OF THE CARTRIDGE WAS NOT POSSIBLE. VISUAL OBSERVATION OF THE EXPOSED PART OF THE CLIP CARTRIDGE, INDICATE THAT THE CARTRIDGE WAS EXTREMELY DAMAGED. THE CLIP APPLIER WAS RETURNED WITH DAMAGES TO THE HAND PIECE AND BAR FEEDER THAT LOOKED TO BE THE RESULT OF EXCESSIVE FORCE OR STRESS. THE TYPE OF FORCE THAT THE HAND PIECE AND CARTRIDGE EXPERIENCED HAVE BEEN NOTED BEFORE. THESE KIND OF DAMAGES THAT WILL CAUSE A MECHANICAL JAM AND OR A DEFECTIVE APPLICATION OF THE PRODUCT. THIS COMPLAINT IS CONFIRMED. 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
    792311 DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART CLIP IMPLANTABLE GCJ MICROLINE SURGICAL INC. 1112 00130788

    Patients

    Seq Age Sex Outcome Treatment
    1