BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 3961825 · Received July 28, 2014

    Report

    Report Number
    3005075853-2014-05268
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE CLIP MALFORMED? DID THE CLIP FALL OFF THE TISSUE? IF SO DID THE CLIP FALL INTO THE PATIENT? WAS THE PROCEDURE ALTERED DUE TO RETRIEVING THE CLIP? PLEASE EXPLAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE MCM30 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS CYCLED AND NO CLIP WAS FED INTO THE JAWS; THE INSTRUMENT WAS BEING ACTUATED IN SEVERAL OCCASIONS, AND NO CLIPS WERE FED. THE DEVICE WAS DISASSEMBLED IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FEEDING INCIDENT. 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 AN UNKNOWN PROCEDURE, THE CLIP WASN'T TIGHT ENOUGH. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439730 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA L4EA07

    Patients

    Seq Age Sex Outcome Treatment
    1