BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP**

    MDR report key: 1832626 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05237
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFORMED CLIP. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIP APPLIER FROM THE SECOND TRAY THEY USED GAVE SEVERAL MALFORMED CLIPS AGAIN. TO FINISH THE PROCEDURE THEY TOOK ANOTHER DEVICE (NOT FROM THE TRAY) THOSE CLIPS FORMED PROPERLY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1