BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX

    MDR report key: 924929 · Received October 10, 2007

    Report

    Report Number
    2183620-2007-00011
    Event Type
    Injury
    Date Received
    October 10, 2007
    Date of Event
    August 29, 2007
    Report Date
    October 9, 2007
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE LOT NUMBERS NOT REPORTED TO MANUFACTURER; THEREFORE, MANUFACTURE AND EXPIRATION DATES UNK. ANASTOMOTIC LEAK IS A COMMON COMPLICATION OF COLO-RECTAL PROCEDURES. DUE TO THIS PATIENT'S CARDIAC AND RESPIRATORY ISSUES IN RECOVERY AND UNDERLYING ALCOHOL DISEASE, IT CANNOT BE DETERMINED WITH CERTAINLY WHAT THE CASE OF THE LEAK MAY HAVE BEEN.

    Description of Event or Problem · 1

    SCHIZOPHRENIC PATIENT HAD A LAPAROSCOPIC RECTO SIGMOID RESECTION FOR COLON CANCER. SURGERY PROCEEDED WITHOUT EVENT USING A 29MM ETHICON CIRCULAR STAPLER AND PSD VERITAS STAPLE LINE BUTTRESS TO CREATE AN ANASTOMOSIS. IN THE RECOVERY ROOM, THE PATIENT BECAME VERY AGITATED AND WAS GIVEN DRUGS TO CALM HER. THE PATIENT SUBSEQUENTLY DEVELOPED RESPIRATORY AND CARDIAC ISSUES REQUIRING TRANSFER TO CCU AND PLACEMENT ON A VENT. THE SURGEON FELT DECOMPENSATION DUE TO CARDIAC AND RESPIRATORY PROBLEMS MAY CAUSE A LEAK. ON POST OPERATION DAY 6, THE PATIENT BECAME SYMPTOMATIC, LOW ANASTOMOTIC FLOW WAS FOUND WITH AN ANASTOMOTIC LEAK. A DRAIN WAS PLACED PERCUTANEOUSLY AND NO ADDITIONAL SURGERY WAS REQUIRED. THE PATIENT HAS BEEN DISCHARGED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY WITH VERITAS COLLAGEN MATRIX STAPLE LINE BUTTRESS FTM SYNOVIS SURGICAL INNOVATIONS PSD 29 E-V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization