BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PI 30-4.8 LARGE DISP. TITANIUM STAPLER

    MDR report key: 1030092 · Received April 16, 2008

    Report

    Report Number
    2647580-2008-00225
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 20, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K911252
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 04/16/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE INSTRUMENT WORKED PROPERLY, BUT AFTER THE BOWEL WAS TRANSECTED AND THE INSTRUMENT WAS REMOVED, IT WAS OBSERVED THAT THE BOWEL WAS NOT STAPLED. THERE WAS LEAKAGE FROM THE OPEN BOWEL (SPECIMEN) END INTO ABDOMEN. A PURSESTRING WAS THEN APPLIED TO THE BOWEL AS NORMAL AND THE LEAKAGE WAS CLEARED. PATIENT'S CURRENT STATUS IS FINE. NO FURTHER PATIENT INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PI 30-4.8 LARGE DISP. TITANIUM STAPLER DISPOSABLE SURGICAL STAPLER GDW PONCE - USS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention