BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3242536 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03683
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. DAMAGED CARTRIDGE, DAMAGED DRIVERS, DAMAGED ONE PIECE SLED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? STOMACH. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNK. ON WHICH FIRING(S) DID THIS EVENT OCCUR? 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? ECR60G. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNK. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE ANALYSIS FOUND THAT ONE ECR60G CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/5. FURTHERMORE, THE CARTRIDGE BODY WAS NOTED TO BE DAMAGED. IN ADDITION, THE RETURNED RELOAD WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED; NO DAMAGE ON DECK WAS FOUND. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE PROCEDURE, ON THE 2ND FIRING WITH NO BUTTRESSING THE SURGEON WAS PULSING THE DEVICE AS USUAL THEN NOTICED A PIECE OF THE SLED CAME APART. THE GREEN CARTRIDGE WAS BENT AND DAMAGED AND LOOKED LIKE THE KNIFE WAS OFF COURSE. THE RELOAD WAS TAKEN OUT. IT WAS NOT MENTIONED IF ANY PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344041 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G