BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 5320071 · Received December 22, 2015

    Report

    Report Number
    3005075853-2015-08314
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    December 9, 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 FOUR 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: HOW MANY CLIPS WERE PLACED? WERE THERE ANY CLIPS FROM THE FIRST DEVICE THAT REMAINED IN PATIENT ON STRUCTURE? WERE THE SCISSORED CLIPS FROM THE FIRST DEVICE REMOVED OR DID THEY REMAIN? ON SECOND DEVICE; WERE THE CLIPS CHECKED? IF SO, WERE THEY FORMED PROPERLY? WHAT IS THE CURRENT PATIENT STATUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLE PROCEDURE THE DEVICE WAS DOUBLE FEEDING AND SCISSORING CLIPS. A SECOND DEVICE WAS PULLED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. ONE DAY POST-OP A LEAK WAS DETECTED. THE PATIENT IS BEING SCHEDULED FOR A ERCP X-RAY AND IS CURRENTLY BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843139 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4J49E

    Patients

    Seq Age Sex Outcome Treatment
    1