BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3922806 · Received July 9, 2014

    Report

    Report Number
    3005075853-2014-04769
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS USER EVER ABLE TO OPEN DEVICE? IF SO, HOW WAS DEVICE OPENED? JAWS LOCKED SHUT, PROMPTING THE SURGEON TO ASK FOR ANOTHER DEVICE. NOT SURE WHAT MEASURES WERE TAKEN TO TRY TO OPEN JAWS, IF ANY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT AN ER420 WAS RECEIVED WITH THE JAWS IN THE CLOSED POSITION. UPON EVALUATION, IT WAS NOTED TO BE EMPTY AND IT WAS FIRED THROUGH LOCKOUT. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED. THE INSTRUMENT WAS DISASSEMBLED AND THE LOCKOUT POSTS WERE NOTED TO BE BROKEN, WHICH DENOTES THAT THE LOCKOUT HAD BEEN FIRED THROUGH. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS PRE-FIRED AND THE JAWS LOCKED CLOSED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399090 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1