BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON* 60 ENDOPATH**

    MDR report key: 2100878 · Received May 24, 2011

    Report

    Report Number
    3005075853-2011-02108
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    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. AFTER SEVERAL ATTEMPTS THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN THE ANALYSIS RESULTS FOUND THAT ONE LONG60 DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITHOUT A CARTRIDGE RELOAD PRESENT. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGE 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 NOTE TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGE FROM THE RELOAD, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OSPHAGOPLASTY PROCEDURE, THE DEVICE WOULD NOT STAPLE BUT CUT. A BLEEDING OCCURRED DUE TO THE LACK OF SUTURE. CONVERSION IN LAPAROTOMY: BIGGER SCAR AND RISK FOR INFECTION INCREASED. SURGERY WAS PROLONGED ONE AND ONE HALF HOUR TO TWO HOURS. A TRANSFUSION WAS NEEDED AND PERFORMED: TWO BLOOD POUCHES. TO DATE THE PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON* 60 ENDOPATH** STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4PV8V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention