BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES

    MDR report key: 1253013 · Received December 9, 2008

    Report

    Report Number
    1527736-2008-03480
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 15, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/04/2008. THE ANALYSIS RESULTS SHOWED THAT ONE EMS INSTRUMENT WAS RECEIVED WITH THE STAPLE MISALIGNED DUE TO AN INSUFFICIENT CARTRIDGE WELD. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MFG TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH HISTORY RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WAS NO STAPLE AFTER THE DEVICE FIRED TEN STAPLES. ANOTHER LIKE DEVICE WAS USED.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 NONE GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1