BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM

    MDR report key: 2232889 · Received September 2, 2011

    Report

    Report Number
    3005075853-2011-03635
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH ONE RELOAD PRESENT. THE RELOAD WAS RECEIVED UNFIRED AND WITH SEVEN STAPLES MISSING FROM THE POCKETS. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. IT SHOULD BE NOTED THAT WHEN MANIPULATING THE DEVICE, ONLY THE CLOSING TRIGGER SHOULD BE GRASPED UNTIL READY TO FIRE THE DEVICE. DO NOT GRASP THE FIRING TRIGGER BEFORE THE DEVICE IS TO BE FIRED. IF THE FIRING TRIGGER IS MANIPULATED, IT COULD CAUSE THE STAPLES TO DEPLOY PARTIALLY OR COMPLETELY RESULTING IN MALFORMED STAPLES AND A PREMATURE LOCKOUT SITUATION. FOR FURTHER DETAILS, PLEASE REFER TO THE INSTRUCTION FOR USE. IN ADDITION, PLEASE NOTE 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. 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 BEFORE AN UNKNOWN PROCEDURE, THE STAPLE DID NOT MOVE FORWARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U03X

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE