BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT - THICK

    MDR report key: 1962240 · Received January 18, 2011

    Report

    Report Number
    3005075853-2011-00230
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE DAMAGED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED WITH THE RIGHT GRIPPING SURFACE BROKEN AND FULLY FIRED. THE INSTRUMENT WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND IT PERFORMED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE GRIPPING SURFACE BECAME DAMAGED, IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; (B)(4). 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 AN UNKNOWN PROCEDURE, SOME UNFORMED STAPLES FELL OUT INSIDE THE PATIENT. IT WAS UNKNOWN WHETHER THE STAPLES FELL OUT AT THE FIRING OR BEFORE THE FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. 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 SAFETY LOCK-OUT - THICK STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA F4MU8V

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD # TRT75, LOT# E4MK2X