BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX

    MDR report key: 5104117 · Received September 25, 2015

    Report

    Report Number
    3005075853-2015-06123
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 8, 2015
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO LOT OR BATCH NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # M53D7G. RESULT COMMENTS: CARTRIDGE, DRIVERS, ONE PIECE SLED THE ANALYSIS FOUND THAT ONE ECR60D CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS AND CARTRIDGE BODY WAS NOTED TO BE DAMAGED. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, THE DEPLOYED STAPLES WERE UNFORMED AT THE SECOND FIRING ON THE UNCUT PART OF THE FIRST FIRING THOUGH THE DEVICE FUNCTIONED AS INTENDED AT THE FIRST FIRING. THE DEVICE WAS USED ON THE RECTUM. THE CARTRIDGE WAS GOLD. IT WAS FOUND THE CARTRIDGE PAN OF THE SECOND CARTRIDGE CAME OFF AFTER THE SECOND FIRING. IT WAS UNKNOWN WHEN THE CARTRIDGE PAN CAME OFF. NO PIECES FELL INTO THE PATIENT. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635653 PWRD ECH FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1