BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MULTIPLE CLIP APPLIER

    MDR report key: 82075 · Received March 3, 1997

    Report

    Report Number
    1527736-1997-00199
    Event Type
    Malfunction
    Date Received
    March 3, 1997
    Date of Event
    January 25, 1997
    Report Date
    March 3, 1997
    Manufacturer
    LACEY MANUFACTURING CO.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION F CORRECTION: ALL INFO SUPPLIED ON THE INITIAL REPORT SHOULD HAVE BEEN NA BECAUSE NO USER FACILITY MEDWATCH REPORT WAS RECIEVED. H6: ADDED EVALUATION CODES (CODE 100 = BOWED FEED CAM) NOTE: FACILITY WAS CONTACTED AND ALL UNK INFO ON THE INITIAL REPORT IS STILL UNK WITH THE EXCEPTION OF THE ADDED ON THIS SUPPLEMENTAL REPORT. CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH A CLIP STICKING OUT OF THE JAW WINDOW AND JAMMED CLOSED. NO TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE INSTRUMENT RETURNED. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A BOWED FEED CAM WHICH CAUSED THE INSTRUMENT TO JAM CLOSE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IF FUNCTIONS PROERLY.

    Description of Event or Problem · 1

    TWO MCM20S WERE USED DURING A CORONARY ARTERY BYPASS. THE CLIPS SPIT OUT OF THE DEVICES. ANOTHER MCM WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/31/97 1401 WAS ASKED TO CALL A DIFFERENT OFFICE. CALLED THE SECOND OFFICE AND WAS NOT ABLE TO LEAVE A MESSAGE. WAS ASKED TO CALL THE FIRST NUMBER ON MONDAY. 2/4/97 1347 MESSAGE AND 800 NUMBER LEFT FOR THE SURGEON TO CALL BACK. 2/5/97 1630 NNCL SENT. 2/13/97 1450 PHYSICIAN'S ASSISTANT RESPONDED TO NNCL. HE STATED THE ONE DEVICE WOULD NOT ADVANCE A CLIP INTO THE JAWS ON THE FIRST FIRING OF THE DEVICE. THE SECOND DEVICE MISFIRED AND WAS DROPPING CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MULTIPLE CLIP APPLIER CLIP APPLIER GDO LACEY MANUFACTURING CO. NA 07012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other