BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3071484 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01917
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OR MANAGER AT THE HOSPITAL ADVISED THAT THIS SURGEON HAD DIFFICULTY OPENING AN ER320 CLIP APPLIER APPROXIMATELY TWO TO THREE YEARS AGO AT A DIFFERENT FACILITY. THE PATIENT DID NOT HAVE AN ADVERSE OUTCOME AS ULTIMATELY SHE WAS ABLE TO REMOVE THE CLIP APPLIER. UPON REVIEW OF THE NEW INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE APPLIER BECOMES LOCKED, MAKING IT DIFFICULT TO REMOVE AND EVEN REQUIRING ENLARGEMENT OF THE INCISION TO REMOVE THE DEFECTIVE EQUIPMENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172651 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention