BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3120235 · Received May 20, 2013

    Report

    Report Number
    3005075853-2013-02415
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS CONFIRMED THAT FIVE DEVICES WERE RECEIVED STERILE AND IN GOOD VISUAL CONDITION. ONE DEVICE WAS OPENED AND TESTED FOR FUNCTIONALITY. THE DEVICE 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. TO REMOVE THE DEVICE OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS FOR EASY REMOVAL. AND TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP LOW ANTERIOR RESECTION, THERE WAS AN UNEXPECTED RESISTANCE WHEN THE DEVICE AND THE ANVIL WERE SET DURING A DOUBLE STAPLING TECHNIQUE FOR RECONSTRUCTION. BESIDES, SOME TARGET TISSUE GOT CAUGHT IN THE DEVICE DURING CLOSING WITH THE ADJUSTING KNOB. IN ADDITION, THE DEVICE HAD A DIFFICULTY IN BEING REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. A LEAK WAS IDENTIFIED AND A DRAIN WAS PLACED. ALTHOUGH THE SURGEON DID NOT GIVE US THE REASON, SURGEON CONSIDERED THAT THE LEAK WAS NOT RELATED TO THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222957 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C96E

    Patients

    Seq Age Sex Outcome Treatment
    1