BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART

    MDR report key: 7013595 · Received November 9, 2017

    Report

    Report Number
    1223422-2017-00135
    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. TWO DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CARTRIDGES ((B)(4)) AND ONE CLIP APPLIER ((B)(4)). A THIRD CLIP CARTRIDGE WAS REPORTED ((B)(4)), BUT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED IN THE ORIGINAL PACKAGING AND UNOPENED. VISUAL INSPECTIONS INDICATE THAT THERE WERE NO SIGNS OF PHYSICAL DAMAGES TO THE DEVICE ((B)(4)). FOR FUNCTIONALLY TESTING THE RETURNED CLIP CARTRIDGE WAS INSERTED INTO A WORKING HAND-PIECE. ALL 19 CLIPS WERE FIRED AND RELEASED WITHOUT HESITATION, JAMMING OR DEFECTS. NO FAILURES WERE OBSERVED. THIS COMPLAINT IS UNCONFIRMED. REF: 1223422-2017-00132, 1223422-2017-00133, 1223422-2017-00134.

    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
    794647 DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART CLIP IMPLANTABLE GCJ MICROLINE SURGICAL INC. 1112 00126119

    Patients

    Seq Age Sex Outcome Treatment
    1