BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED PLUS LONG 45

    MDR report key: 8861425 · Received August 5, 2019

    Report

    Report Number
    3005075853-2019-21040
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    June 5, 2019
    Report Date
    June 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015345
    PMA / PMN Number
    K163454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # T5AG7K. ADDITIONAL INFORMATION RECEIVED: IS THE CURRENT PATIENT STATUS KNOWN? YES, COMPLETE SURGERY WITHOUT ANY PROBLEMS WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.) NO CONSEQUENCE TO PATIENT. INVESTIGATION SUMMARY: THE ANALYSIS RESULTS THAT ONE PLEE45A DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCE'S AND WITH TWO CARTRIDGE RELOADS PRESENT. THE RELOAD (B) WAS RECEIVED BROKEN, FULLY FIRED AND WITH THE PAN DISLODGED. THE RELOAD (C) WAS RECEIVED FULLY FIRED. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGED INSIDE THE CHANNEL. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT IS ALSO POSSIBLE THAT HANDLING BY THE CUSTOMER COULD DISLODGE THE PAN. DISLODGEMENT AS A RESULT OF THE REMOVAL OF THE CARTRIDGE FROM THE DEVICE IS THE MOST LIKELY SCENARIO. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. RELOAD B: GST45B, T5AK5F, FULLY FIRED, BROKEN AND WITH THE PAN DISLODGED. RELOAD C: GST45B,T5AK5F, FULLY FIRED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE POWERED ENDOCUTTER WAS LOADED WITH A CARTRIDGE AND DID FUNCTION BUT WHEN REMOVING THE USED CARTRIDGE FROM THE STAPLER THE METAL PART OF THE CARTRIDGE STAYED IN THE JAWS OF THE STAPLER AND THEREFORE THE STAPLER COULD NOT GET RELOADED. PATIENT CONSEQUENCES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656758 POWERED PLUS LONG 45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. T92F13 10705036015345

    Patients

    Seq Age Sex Outcome Treatment
    1