BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERI-STRIPS DRY WITH VERITAS

    MDR report key: 633218 · Received September 1, 2005

    Report

    Report Number
    2183620-2005-00009
    Event Type
    Other
    Date Received
    September 1, 2005
    Date of Event
    August 11, 2005
    Report Date
    August 31, 2005
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPARASCOPIC ROUX-EN-Y GASTRIC BYPASS, A 21 ETHICON CIRCULAR STAPLER WITH CIRCULAR BUTTRESS WAS USED DURING THE CREATION OF A G-J CIRCULAR ANASTOMOSIS. AFTER CREATING THE ANASTOMOSIS, THE CIRCULAR STAPLER COULD NOT BE REMOVED THROUGH THE BUTTRESSED ANASTOMOSIS. IN ORDER TO REMOVE THE STAPLER, THE CARTRIDGE AND ANVIL STAPLER COMPONENTS WERE DISCONNECTED AND RETRIEVED SEPARATELY. THE JEJUNUM WAS EVERTED TO GAIN ACCESS TO THE ANVIL SHAFT AND THEN MANIPULATED THROUGH THE ANASTOMOSIS LUMEN THIS INCREASED SURGERY TIME. AN INTRA-OPERATIVE METHYLENE BLUE TEST WAS CONDUCTED AND DEMONSTRATED NO SIGNS OF ANASTOMOTIC LEAK. THE REMAINDER OF THE SURGICAL PROCEDURE WAS PERFORMED AS USUAL. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY WITH VERITAS STAPLE LINE BUTTRESS FTM SYNOVIS SURGICAL INNOVATIONS PSD 21-E-V 5713058-221866

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization