BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3242608 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03680
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE STAPLES MALFORMED? 4-5 STAPLES DID NOT FORM. WAS THE STAPLE LINE INCOMPLETE? NO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 3RD ON THE DEVICE, 1ST WITH THE WHITE RELOAD. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? YES, GORE SEAM GUARD. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. 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 ROBOTIC LAPAROSCOPIC GASTRIC ROUX-EN-Y BYPASS PROCEDURE, ONE PARTIAL SIDE OF THE STAPLE LINE DIDN'T FORM (4-5 STAPLES) WHEN FIRING ACROSS THE JEJUNUM USING A WHITE RELOAD. A BLUE RELOAD WAS USED SUCCESSFULLY IMMEDIATELY BELOW THE FAILED WHITE FIRING. THE STAPLES FORMED COMPLETELY AND THE CASE WAS CONTINUED AS USUAL. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343247 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1