BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360- ROTATION 20 TITANIUM STAPLES

    MDR report key: 1032240 · Received April 18, 2008

    Report

    Report Number
    1527736-2008-02281
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Report Date
    March 13, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE 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. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP. HERNIA PROCEDURE THAT THE DEVICE DID NOT STAPLE. THERE WAS NO PT CONSEQUENCE.

    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. (CINCINNATI) NA D4HC14

    Patients

    Seq Age Sex Outcome Treatment
    1