BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 3925978 · Received June 30, 2014

    Report

    Report Number
    1219930-2014-00491
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC SIGMOID. ACCORDING TO THE REPORTER: DURING STAPLING/CUTTING OF THE VASCULARIZATION (SIGMOID ARTERY) WITH THE WHITE SULU, THE STAPLES DIDN'T STAPLE. THE KNIFE CUT THE VESSEL BUT NO STAPLES WERE FORMED IN A B SHAPE. THE STAPLES WERE OPEN AND SOME WERE COMPRESSED. THE SIGMOID ARTERY HAD A NORMAL SIZE. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THE INCISION WAS EXTENDED BY 30 CM DUE TO CONVERSION OF PROCEDURE FROM LAPAROSCOPY TO LAPAROTOMY. THERE WAS 600CC OF BLOOD LOSS. NO BLOOD TRANSFUSION WAS NECESSARY. SURGERY TIME WAS EXTENDED BY 60MIN. THIS PATIENT WAS AT THE HOSPITAL FOR 14 DAYS. AFTER SEVEN DAYS, THERE WAS A SERIOUS CHANGE IN PATIENT STATUS. THE PATIENT WAS SUSPECTED TO HAVE A MICROLEAKAGE BUT CT ABDOMEN SHOWED NO LEAKAGE. PATIENT WAS IN PAIN, BUT RECOVERED SPONTANEOUSLY AND COULD GO HOME AFTER 14 DAYS. CURRENTLY PATIENT AT HOME IN GOOD CONDITION. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378684 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN LP, FORMERLY US SURGICAL N3K1235X

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R LOT #: N3J0248LX, MANUFACTURE DATE: 09/2013,| EXP DATE: 09/30/2018, (B)(4)| ENDO GIA ROTICULATOR 60-2.5 SULU, (B)(4),