BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3833651 · Received May 27, 2014

    Report

    Report Number
    3005075853-2014-03570
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 6, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) = RETURNED EMPTY. THE ANALYSIS RESULTS FOUND THAT THE ER320 DEVICE WAS RECEIVED WITH A CLIP IN JAWS AND IN GOOD VISUAL CONDITION; THE JAWS PROPERLY ALIGNED. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT. THE DEVICE IS DESIGNED TO LOCK OUT WHEN ALL THE CLIPS HAVE BEEN FIRED. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE INCIDENT REPORTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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, SLIPPED OFF DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, SLIPPED OFF DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310459 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4EA1M

    Patients

    Seq Age Sex Outcome Treatment
    1