BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QTY INVOLVED:

    MDR report key: 2937919 · Received January 31, 2013

    Report

    Report Number
    3005075853-2013-00402
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. ADDITIONAL INFORMATION: HOW WAS THE PROCEDURE PERFORMED? (OPEN, LAP, OR HAS) OPEN. WHAT TYPE OF PROCEDURE WAS THE DEVICE USED IN? ESOPHAGEAL CARCINOMA. WHERE THE LOCKING SPRINGS DEPRESSED WHEN ATTEMPTING TO ATTACH THE DETACHABLE HEAD ASSEMBLY? NO. DID THE ANVIL FALL INTO THE PATIENTS BODY CAVITY? IF, YES WAS IT RETRIEVED? NO. WAS THE SALES REPRESENTATIVE PRESENT? NO. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? MORE THAN 3 YEARS. WAS THE ATTENDING SURGEON AN EXPERIENCED EES CIRCULAR USER? YES. WAS THE PERSON FIRING THE DEVICE AN EXPERIENCED EES CIRCULAR USER? (Y/N) YES. WAS THE O.R. STAFF EXPERIENCED IN PREPARING THE EES CIRCULAR DEVICE? (Y/N) YES. WAS THERE A RECENT CONVERSION TO EES DEVICES WITH THIS ACCOUNT OR WITH THIS SURGEON? NO. IS THERE ANY ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE RELATIVE TO THE ISSUE? NO. WHAT IS THE PATIENTS PRESENT CONDITION? FINE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT AND THERE WERE STAPLES PRESENT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRE. THE DEVICE WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE ANVIL WAS PLACED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES. ALTHOUGH THERE IS NO CONCLUSION AS TO WHAT CAUSE THE REPORT INCIDENT IT IS POSSIBLE THAT THE ANVIL WAS GRIPPED BY THE LOCKING SPRINGS WHILE TRYING TO REATTACHED TO THE DEVICE; THIS WOULD PREVENT THE ANVIL LOCKING ON TO THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ANVIL COULD NOT BE FIRMLY ATTACHED DURING USE. 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
    42963 QTY INVOLVED: STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C425

    Patients

    Seq Age Sex Outcome Treatment
    1