BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3230259 · Received July 16, 2013

    Report

    Report Number
    3005075853-2013-03583
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 19, 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). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.DEVICE NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE, DAMAGED ONE PIECE SLED, DAMAGED DRIVERS. THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60D LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE LEFT SIDE PARTIALLY FIRED 1/2, RIGHT SIDE TWO INNER ROWS FULLY FIRED AND RIGHT SIDE OUTER ROW PARTIALLY FIRED 1/4. 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. ADDITIONALLY THE CARTRIDGE PAN WAS NOTED TO BE PARTIALLY DISENGAGED AND DAMAGE AT RIGHT SIDE PROXIMAL END. DURING FURTHER EVALUATION, THE DEVICE WAS NOTED TO BE NON FUNCTIONAL. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, EVIDENCES OF CORROSION WERE NOTED ON THE MOTOR. PLEASE NOTE 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. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE MOTOR. 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 AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT STAPLE BUT CUT. THERE WAS A PROBLEM WITH THE MAGAZINE OR WITH THE CLIP: IMPOSSIBLE TO STAPLE OF HALF LENGTH ALTHOUGH THE TISSUE HAVE BEEN CUT. ON THE CHARGER, IT WAS FOUND THAT THE STAPLES WERE TRAPPED. THE INCIDENT OCCURRED DURING THE THIRD USE (3RD MAGAZINE). THE SET HAS BEEN CHANGED (CLIP + MAGAZINE). IT WAS IMPOSSIBLE TO DETERMINE WHETHER THE PROBLEM IS WITH THE CLIP OR CHARGER. 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
    328965 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C18R

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60D