BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART

    MDR report key: 7013620 · Received November 9, 2017

    Report

    Report Number
    1223422-2017-00133
    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 INITIAL COMPLAINT REPORTED 3 CLIP CARTRIDGES BEING RETURNED AND 1 CLIP APPLIER. MICROLINE SURGICAL ONLY RECEIVED 2 CLIP CARTRIDGES. ONE WAS JAMMED IN THE CLIP APPLIER AND ONE WAS IN AN UNOPENED POUCH. THE CLIP CARTRIDGE RELATED TO THIS MDR WAS NOT RECEIVED. REF: 1223422-2017-00132, 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
    793772 DISPOSABLE 19 MEDIUM/LARGE TITANIUM K2 CLIP CART CLIP IMPLANTABLE GCJ MICROLINE SURGICAL INC. 1112 00130792

    Patients

    Seq Age Sex Outcome Treatment
    1