BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP MCA SMALL

    MDR report key: 3212817 · Received July 9, 2013

    Report

    Report Number
    3005075853-2013-03454
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 16, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT PROCEDURE WAS BEING PERFORMED? WHAT STRUCTURE(S) WERE THE CLIPS PLACED ON? WERE THERE ANY PROBLEMS WITH THE DEVICE DURING THE INITIAL PROCEDURE? WHAT DID THE CLIP FORMATION LOOK LIKE DURING THE INITIAL PROCEDURE? WAS THE SURGEON ABLE TO OBSERVE PROPER FORMATION OF THE CLIPS PRIOR TO CLOSING THE PATIENT? HOW LONG POST OPERATIVE DID THE PATIENT PRESENT WITH SYMPTOMS OF A LEAK? DURING THE REOPERATION WHAT WAS FOUND? WHERE EXACTLY WAS THE LEAK FOUND? WERE THE CLIPS PRESENT? IF SO, WHAT DID THE CLIP FORMATION LOOK LIKE? WHAT WAS DONE TO ADDRESS THE LEAK? WERE THERE ANY OTHER FACTORS THAT MAY HAVE LED TO THE LEAK? WHAT IS THE PATIENT¿S CURRENT STATUS? IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PATIENT HAD TO BE REOPENED DUE TO LEAKAGE CAUSED BY THE CLIPS NOT COMPLETELY CLOSED. DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313632 LIGACLIP MCA SMALL CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention