BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH SURGIDAC 2/0 7 GRN DLU SU

    MDR report key: 1630752 · Received March 11, 2010

    Report

    Report Number
    1219930-2010-00200
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE RPTR: THE SURGEON FELT LIKE THERE WAS A KNOT WHERE THE SUTURE ATTACHED TO THE NEEDLE AND WHILE TOGGLING THROUGH TISSUE NOTICED THAT IT WAS CATCHING AND TEARING TISSUE. SURGEON CHANGED THE SULU TO COMPLETE THE CASE WITHOUT INCIDENT. THE SURGEON THEN HAD TO OVER SEW THE TORN TISSUE. SOME ADDITIONAL BLEEDING OCCURRED. OPERATIVE TIME WAS DELAYED ONLY A FE EXTRA MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 2/0 7 GRN DLU SU ABSORBABLE SUTURING DEVICE MFJ UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHCARE GROUP N9K0513

    Patients

    Seq Age Sex Outcome Treatment
    1 Other