BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1993046 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00630
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 21, 2011
    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). NO DEVICE RETURN. THE ANALYSIS RESULTS FOUND THAT THE TRT75 RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION AND FULLY FIRED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE STAPLE LINE WAS NOT INTACT. THEY HAD TO TAKE ANOTHER DEVICE IN ORDER TO STAPLE AGAIN. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4UD6Y

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD TRT75, LOT G4TNG4