BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER RELOAD - THICK

    MDR report key: 1840454 · Received September 21, 2010

    Report

    Report Number
    3005075853-2010-05442
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 14, 2010
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WAS MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE SURGEON NOTICED THAT SEVERAL OF THE STAPLES DID NOT CURL DOWN CORRECTLY. THESE WERE ON THE SPECIMEN TO BE REMOVED. THERE WAS NO PATIENT IMPACT. THE CARTRIDGE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** LINEAR CUTTER RELOAD - THICK STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TG0K

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE