BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3061955 · Received April 16, 2013

    Report

    Report Number
    3005075853-2013-01830
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE EXTENDED OR TIME HAVE ANY AFFECT ON THE POST-OP CARE OF THE PATIENT? NO, IT HASN´T HAD ANY EFFECT ON THE POST-OP CARE OF THE PATIENT. THE ANALYSIS RESULTS FOUND THAT TWO TR45G RELOADS WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. IN ADDITION, THE RETURNED RELOADS WERE DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND NO ABNORMALITIES WERE FOUND. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. 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 A RESECTION OF ESOPHAGUS PROCEDURE THE STAPLES WERE NOT PRESENT IN THE CARTRIDGE ON THE FIRST DEVICE AND ON THE SECOND DEVICE THERE WAS A MALFORMATION OF STAPLES, FIRING WAS BLOCKED IN THE FIRST 1/3. PATIENT IS STABLE. THE PROCEDURE WAS PROLONGED BY 30 MINUTES. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162955 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1