BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3891395 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04303
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    February 16, 2014
    Report Date
    April 30, 2014
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RETURNED WITH A MALFORMED CLIP JAMMED IN JAWS AND IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED AND FED AND FORMED 1 SCISSORED CLIP, AND THEN THE REMAINING CLIP WAS FORMED AS INTENDED. IN ADDITION THE DEVICE LOCKED OUT AS INTENDED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE JAMMED CLIP IN THE JAWS AND THE SCISSORED CLIP FOUND DURING TESTING. 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 AN UNKNOWN PROCEDURE, THE HEMOCLIP ADVANCED AND DIDN'T FIRE. THERE WERE NO PATIENT CONSEQUENCES. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367762 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1