BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD FOR ECHELON

    MDR report key: 2982289 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00899
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. TO CLARIFY: WAS THE STAPLE LINE OPEN DUE TO MALFORMED STAPLES OR DID NOT STAPLES DEPLOY IN THAT AREA? WHAT DEVICE/PRODUCT CODE WERE THEY USING WITH THE CARTRIDGE RELOAD? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? ECHELON STRAIGHT/FLEX: DURING WHICH STROKE DID THE EVENT OCCUR? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BYPASS SURGERY THE END PART OF THE STAPLE LINE WAS "OPEN". BEFORE THIS SURGERY THE PATIENT HAD A GASTRIC BAND AND THE TISSUE HAD STRONG SCARRING IN THIS AREA. THIS LAST PASSAGE HAS BEEN STAPLED WITH TRI-STAPLE (COVIDIEN) BUT THE SURGEON HAS TO OVERSTITCH IT. NO PATIENT CONSEQUENCES REPORTED. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85964 GOLD RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1