BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 4854551 · Received June 18, 2015

    Report

    Report Number
    3005075853-2015-03731
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    April 24, 2015
    Report Date
    June 3, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS OF THE EL5ML DEVICE FOUND THAT IT WAS RECEIVED WITH DRIED BODY FLUIDS. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND THE CLIPS COULD NOT FULLY ADVANCE DUE TO THE DRIED BODY FLUIDS; THIS CONDITION LED TO THE MALFORMATION OF FIVE CLIPS WITH GAP; AFTER THAT, FIVE CONFORMING CLIPS WERE FED AND FORMED. UPON EVALUATION THE TRIGGER WAS DIFFICULT TO CYCLE DUE TO THE ACCUMULATION OF BODY FLUIDS. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP APPLIER DID NOT WORK. AFTER TWO FIRINGS IT DID NOT GAVE ANY CLIPS. THE FIRST TWO WERE MALFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397500 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4H40J

    Patients

    Seq Age Sex Outcome Treatment
    1