BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 5082887 · Received September 16, 2015

    Report

    Report Number
    3005075853-2015-05873
    Event Type
    Injury
    Date Received
    September 16, 2015
    Report Date
    August 28, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # M9226K. 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 CLIPS AS INTENDED. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE SCISSORING UPON PLACEMENT. THE SURGEON INSPECTED THE DUCT AND FOUND THE CLIPS DID NOT HOLD ON THE DUCT. THE SURGEON RESORTED TO USING AN UNSPECIFIED MANUAL DEVICE TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE THE PATIENT WAS FOUND TO HAVE A LEAK AND WAS HOSPITALIZED FOR SEVENTEEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614325 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4HV3F

    Patients

    Seq Age Sex Outcome Treatment
    1