BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3770726 · Received April 24, 2014

    Report

    Report Number
    3005075853-2014-02796
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 30, 2014
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT INDICATED THAT THE PLASTIC COVERING OF THE STAPLER DEVICE HAD A HOLE. THE PLE60A DEVICE WAS RETURNED IN BUBBLE-WRAP WITHOUT ANY PACKAGING MATERIALS. COMPLAINT EVENT COULD NOT BE CONFIRMED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WAS THE HOLE IN THE TYVEK? YES. WAS THE STERILITY COMPROMISED: YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A GASTRIC SLEEVE PROCEDURE, THE SCRUB TECH NOTICED THAT THE PLASTIC PROTECTIVE COVERING OF THE STAPLER HAD A WHOLE IN IT. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249092 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E84H

    Patients

    Seq Age Sex Outcome Treatment
    1