BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC MULTIFEED

    MDR report key: 1873251 · Received October 18, 2010

    Report

    Report Number
    3005075853-2010-05919
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K913469
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, THE STAPLES WOULD NOT HOLD. THE STAPLES DID NOT CLOSE ON THE TISSUES. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC MULTIFEED LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4T044

    Patients

    Seq Age Sex Outcome Treatment
    1