BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1850422 · Received September 20, 2010

    Report

    Report Number
    3005075853-2010-05363
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    June 15, 2010
    Report Date
    August 26, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THERE WAS AN INCOMPLETE STAPLE LINE. WITH TWO SUCCESSIVE STAPLERS DURING THE SAME PROCEDURE, THE SURGEON REPORTED A FAILURE OF THE STAPLES, WITHOUT PROVIDING FURTHER DETAILS, DESPITE SEVERAL CALLS AND EMAILS. IN BOTH CASES, THE METHYLENE BLUE TEST REVEALED A 1 CM GAP OF THE ANASTOMOSIS, WITHOUT STAPLES. NO DETAILS ON THE RESOLUTION OF THE ISSUE WERE PROVIDED BY THE SURGEON: HE STATED THAT HE DOESN'T CLEARLY REMEMBER THE EVENT. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4RHY9

    Patients

    Seq Age Sex Outcome Treatment
    1