BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3013000 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01317
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PACKAGING LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT OR DETERMINE THE CAUSE POTENTIAL/PROBABLE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTOSIGMOIDECTOMY PROCEDURE, THE STAPLER DID NOT STAPLE. 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
    115450 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C48F

    Patients

    Seq Age Sex Outcome Treatment
    1