BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 5320025 · Received December 22, 2015

    Report

    Report Number
    3005075853-2015-08313
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    December 4, 2015
    Report Date
    December 10, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 1/11/2016. (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED WITH A CLIP IN THE JAWS; THE CLIP WAS REMOVED IN ORDER TO INSPECT THE JAWS AND THEY WERE FOUND TO BE IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED, RETAINED AND FORMED THE REMAINING TWO CLIPS AS INTENDED. AS THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH # UNK. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE, THE CLIPS WERE NOT CLOSING COMPLETELY. A SECOND DEVICE WAS PULLED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. ON (B)(6) 2015 TWO DAYS POST-OP, THE PATIENT RETURNED TO THE HOSPITAL AND WAS RE-ADMITTED FOR A LEAK. A ERCP WAS PERFORMED AND THE PATIENT IS CURRENTLY BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845130 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4J49E

    Patients

    Seq Age Sex Outcome Treatment
    1