BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE CUTTER RELOAD GOLD

    MDR report key: 2923952 · Received January 22, 2013

    Report

    Report Number
    3005075853-2013-00290
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 29, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE. RELOAD B: BATCH# J5FK10. MANUFACTURED DATE: 02/15/2012. EXPIRATION DATE: 01/15/2017. TWO RELOADS WERE RECEIVED. RELOAD A WAS FULLY FIRED AND WITH THE FORKS BROKEN OFF. RELOAD B WAS FULLY FIRED AND LOCKED. NO FUNCTIONAL WAS TEST PERFORMED. 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. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE MALFORMED AT THE DISTAL PART. TWO RELOAD UNITS HAD SAME PROBLEM. CHANGED NEW DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30575 PROXIMATE CUTTER RELOAD GOLD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1