BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2181076 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03035
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH THE TOP AND LOWER SHROUD BROKEN CAUSING THAT THE CLIPS TO BE EJECTED. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 TO A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, A SCRUB NURSE FIRED THE DEVICE TO CHECK ITS FUNCTION BEFORE USE ON THE PATIENT, AND A CLIP EJECTED. THE EVENT OCCURRED SEVERAL TIMES, AND THEN A DEFORMED CLIP JAMMED IN THE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1