BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED STAPLER - 360 ROTATION 20 TITANIUM STAPLES

    MDR report key: 1003651 · Received February 14, 2008

    Report

    Report Number
    1527736-2008-00875
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Report Date
    December 27, 2007
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 02/14/2008. INSTRUMENT A AND E: DAMAGED FIRING MECHANISM. INSTRUMENT B, C, D, F: THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE A WAS RETURNED NON-FUNCTIONAL DUE TO A BROKEN LIFTER. IN ADDITION, THE CARTRIDGE NOSE WAS NOTED TO BE BROKEN, HOWEVER, THE WELD WAS SUFFICIENT. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS SHOWED THAT THE EMS DEVICE B WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED AND IT WAS CYCLED, FED, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES NOTED. D5KK8H. THE ANALYSIS RESULTS SHOWED THAT THE EMS DEVICE C WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED AND IT WAS CYCLED, FED, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES NOTED. THE ANALYSIS RESULTS SHOWED THAT THE EMS DEVICE D WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED AND IT WAS CYCLED, FED, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES NOTED. THE ANALYSIS RESULTS SHOWED THAT ONE EMS DEVICE E WAS RETURNED NON-FUNCTIONAL DUE TO A BROKEN LIFTER. NO FUNCTIONAL TEST WAS PERFORMED. THE ANALYSIS RESULTS SHOWED THAT THE EMS DEVICE F WAS RECEIVED IN GOOD VISUAL CONDITION. THE DEVICE WAS TESTED AND IT WAS CYCLED, FED, AND FORMED ALL THE REMAINING STAPLES AS INTENDED. THE STAPLES WERE NOTED TO HAVE THE PROPER BOX SHAPE AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES NOTED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION 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 DEVICE DID NOT FIRE AT ALL. THE CASE WAS COMPLETED WITH A SAME LIKE DEVICE. PATIENT CONSEQUENCE UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

    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 D4J67E

    Patients

    Seq Age Sex Outcome Treatment
    1