BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR* 60-3.5 SULU

    MDR report key: 4231350 · Received November 6, 2014

    Report

    Report Number
    1219930-2014-01012
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: CUSTOMER STATED THAT DURING THE SURGERY OF RECTAL LOW RESECTION, THE DOCTOR USED ENDOGIA AND STAPLE CARTRIDGE 030458 TO CLOSE AND DIVIDE THE TISSUE. AFTER THE STAPLE CARTRIDGE WAS FIRED, IT WENT AHEAD FOR 0.5CM, THEN IT WASN'T ABLE TO BE CONTINUED TO BE FIRED, OR TO OPEN THE JAW. THE JAW LOCKED A SMALL PART OF THE TISSUE. BUT IT WAS RELATIVELY EASY TO REMOVE THE DEVICE FROM THE TISSUE. THE SURGEON USED GRASPING FORCEPS AND INSERTED IT INTO THE GAP WITHIN THE RELOAD TO EXPAND THE JAW GAP, THEN REMOVED THE RELOAD FROM THE TISSUE. THEN NEW STAPLE WAS USED TO CONCLUDE THE SURGERY. THE INCOMPLETE STAPLE LINE WAS RESECTED AND RE-STAPLED. SURGERY TIME DID NOT EXTEND OVER 30 MINUTES. THERE WAS NO BLOOD LOSS OF OVER 500CC'S. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714478 ENDO GIA ROTICULATOR* 60-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON 030458 N3A0042LX

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability