BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3851716 · Received June 5, 2014

    Report

    Report Number
    3005075853-2014-03803
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    March 31, 2014
    Report Date
    May 14, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ER320 DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY; HOWEVER, THE LOCKOUT MECHANISM WAS NOT FUNCTIONAL. DUE TO THE RETURNED CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. THE DEVICE WAS DISASSEMBLED IN ORDER TO EVALUATE THE CONDITION OF INTERNAL COMPONENTS AND EXCESSIVE SILICONE WAS FOUND ALONG THE SHAFT; THIS CONDITION PREVENTED THE FEEDER SHOE TO MOVE FORWARD AND THEREFORE THE LOCKOUT MECHANISM WAS NOT ACTIVATED. UPON INSPECTION, THE FEEDER SHOE COULD BE ACCOMMODATED AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. THE DEVICE RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WHILE CLIPPING THE CYSTIC DUCT AND ARTERY WHILE SOME CLIPS CLOSED CORRECTLY SOME OTHERS WERE LOSE AND WERE NOT CLOSING COMPLETELY. AFTER THE FIRST ONE FAILED, THE DOCTOR OPENED A SECOND ONE WHICH ALSO FAILED. THE THIRD ONE WORKED PROPERLY. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328939 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4DK1P

    Patients

    Seq Age Sex Outcome Treatment
    1