BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT, 100 MM

    MDR report key: 1100146 · Received August 5, 2008

    Report

    Report Number
    1527736-2008-03906
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Report Date
    May 30, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANVIL MISALIGNED/MALFORMED STAPLES. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION, AND WITH FOUR RELOADS PRESENT. ALL OF THE RELOADS WERE RETURNED VOID OF STAPLES. THE KNIFE WAS NOTED TO HAVE NICKS; THIS DAMAGE IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED ALL THE STAPLES. HOWEVER, 14 STAPLES WERE MALFORMED. AFTER FURTHER ANALYSIS, THE ANVIL WAS NOTED TO BE MISALIGNED AS THE KNIFE SLOT WAS OFF CENTERED. THIS WILL MISALIGN THE ANVIL AND THE CARTRIDGE, PREVENTING SOME STAPLES FROM HITTING THE ANVIL POCKETS AND THUS MALFORMING. A BATCH RECORDS REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DEVICE DID NOT FIRE AT ALL. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT, 100 MM GDW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI