BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** CLIP APPLIER - SMALL - 19 CM

    MDR report key: 3043533 · Received April 9, 2013

    Report

    Report Number
    3005075853-2013-01664
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE FIRED MALFORMED CLIPS. IT IS NOT KNOWN IF THIS WAS DURING TESTING OR IN A PROCEDURE. NO OTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144816 LIGACLIP** CLIP APPLIER - SMALL - 19 CM APPLIER, SURGICAL, CLIP GDO ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1