BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 2598372 · Received April 26, 2012

    Report

    Report Number
    1219930-2012-00395
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    March 20, 2012
    Report Date
    April 24, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL IS IN PROCESS.

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC LOW ANTERIOR RESECTION ACCORDING TO THE REPORTER: AFTER INSERTING THE STAPLER WITH A 60CM SULU, THE SURGEON FOUND THAT IT WAS NOT EASY TO POSITION AND DID NOT FIRE THE DEVICE. THE SURGEON CHANGED TO A 45CM SULU. AFTER FIRING, SURGEON PULLED BACK THE BLACK BUTTON TO THE END OF THE STAPLER, HOWEVER, THE KNIFE BLADE COULD NOT BE RETRACTED AND THE JAW COULD NOT BE OPENED. THE SURGEON OBSERVED THAT THE TISSUE HAD BEEN CUT AND STAPLED. SO, HE TRIED TO USE ANOTHER CLAMP TO OPEN THE JAW BY MECHANICAL FORCE AND SEPARATED THE RECTUM TISSUE OUT FROM THE SULU. FINALLY, THE RECTUM WAS CUT AND STAPLED. THE JAW REMAIN CLOSED AND KNIFE BLADE CANNOT BE RETRACTED. SURGERY TIME WAS EXTENDED BY APPROX. 30 MINUTES. THE SURGEON HAS PERFORMED ANOTHER SURGERY LATER FOR THE TEMPORARY COLOSTOMY TO HAVE FASTER WOUND HEALING OF THE LOWER RECTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N1C0513X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S LOT# N9G0602, EXPIRATION DATE: 7/31/2014| ENDO GIA ROTICULATOR 45-4.8 SULU: (B)(4)| MFR DATE 07/01/2009