BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 3052482 · Received April 11, 2013

    Report

    Report Number
    3005075853-2013-01728
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 20, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. ADDITIONAL INFORMATION PROVIDED: ON WHICH FIRING OF THE DEVICE DID THE EVENT OCCUR? THIRD FIRING. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE? MIDDLE OF STAPLE LINE. WHERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS? UNKNOWN. WHERE THE STAPLE LEGS UNFORMED OR DID THEY HAVE IRREGULAR SHAPES? UNKNOWN. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF BUTTRESSING MATERIAL WAS USED, WHAT PRODUCT? NO. WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY WHEN PERFORMING GASTROJEJUNOSTOMY THE STAPLE WAS MALFORMED CAUSING THE SURGEON TO OVER SEW THE ENTIRE STAPLE LINE. ACCORDING TO THE SURGEON THIS WORKED OUT OK FOR THE PATIENT. NO LEAKAGE AFTERWARDS. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156773 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1