BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1933229 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07264
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 19, 2010
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP. THE ANALYSIS RESULTS OF THE EL5ML DEVICE (B) FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; ONE MALFORMED CLIP WAS RELEASED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. THE DEVICE LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR DID NOT SHOW UP COMPLETELY. PLEASE NOTE THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THIS ISSUE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUBFASCIAL ENDOSCOPIC PERFORATOR SURGERY, THE DEVICE WAS TAKEN OUT OF THE PACKAGING AND THE SCRUB NURSE HANDED THE DEVICE TO THE SURGEON. THE SURGEON CLOSED THE JAWS OF THE DEVICE TO RELEASE THE CLIP; HOWEVER, THE CLIPS DID NOT COME OUT OF THE JAWS OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TG67

    Patients

    Seq Age Sex Outcome Treatment
    1