BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STRAIGHT INTRALUMINAL STAPLER - 29MM

    MDR report key: 1163343 · Received September 10, 2008

    Report

    Report Number
    3005075853-2008-01618
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT WOULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MFG RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WAS FIRED AND IT WAS NOTED THAT NOT ALL OF THE STAPLES HAD FORMED. A COUPLE OF THE STAPLES REMAINED IN THE DEVICE BUT HAD BEEN PUSHED UP BY THE STAPLE DRIVERS. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STRAIGHT INTRALUMINAL STAPLER - 29MM GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1