BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP**

    MDR report key: 1821632 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04974
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 5, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GALL BLADDER PROCEDURE, THE CLIPS WOULD NOT ADVANCE. UPON THE FIRST ACTIVATION THE CLIP WOULD NOT ADVANCE BETWEEN THE JAWS. THEN THE FOLLOWING CLIPS WERE DELIVERED ONLY ONE OUT OF TWO TIMES. A NEW APPLIER WAS USED WITHOUT FURTHER ISSUE. 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 G4T47V

    Patients

    Seq Age Sex Outcome Treatment
    1