BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360? ROTATION 20 TITANIUM STAPLES

    MDR report key: 1032245 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02286
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 04/18/2008. INSTRUMENT A: DAMAGED LIFTER SPRING. INSTRUMENT B: INSUFFICIENT CARTRIDGE WELD. EVAL SUMMARY: THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE A WAS RETURNED NON-FUNCTIONAL DUE TO A DAMAGED LIFTER. NO FUNCTIONAL TEST WAS PERFORMED. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGED TO THE LIFTER OCCURRED; IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE B WAS RETURNED WITH THE NOSE OPEN AND NON-FUNCTIONAL DUE TO AN INSUFFICIENT CARTRIDGE NOSE WELD. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP HERNIA PROCEDURE THE FIRST DEVICE DID NOT FIRE AND THE SECOND DEVICE ONLY THREE STAPLES FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE. BOTH DEVICE TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED STAPLER - 360? ROTATION 20 TITANIUM STAPLES GCJ ETHICON ENDO-SURGERY, INC. NA D4H879

    Patients

    Seq Age Sex Outcome Treatment
    1