BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2963261 · Received February 15, 2013

    Report

    Report Number
    3005075853-2013-00635
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT INDICATED AN OPEN SEALED PACKAGE. NO PACKAGING MATERIALS WERE RETURNED FOR EVALUATION. ONLY THE INSTRUMENT, WITH THE TIP IN BUBBLE-WRAP WAS RETURNED. THE COMPLAINT CANNOT BE CONFIRMED AS PACKAGE WAS NOT RETURNED FOR ANALYSIS. PACKAGING MATERIAL WAS REQUESTED AS NOTED IN PI NOTES SECTION. IF PACKAGING IS RETURNED, AN ANALYSIS WILL BE PERFORMED ON THE RETURNED MATERIALS. LOT HISTORY RECORDS WERE REVIEWED; NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED. LOT HISTORY RECORDS WERE REVIEWED. NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THERE WAS AN OPEN SEALED PACKAGE. AT THE OPENING OF THE DEVICE, THE SURGEON REALIZED THAT THE BLISTER WAS POORLY SEALED, NOT STERILE. NOT USED ON THE PATIENT. 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
    67616 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4AR05

    Patients

    Seq Age Sex Outcome Treatment
    1