BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

    MDR report key: 1913803 · Received November 24, 2010

    Report

    Report Number
    2183620-2010-00057
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    July 20, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K083039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED. ACCORDING TO THE DEVICE HISTORY RECORD, THE DEVICE MET SPECIFICATION AT THE TIME OF MANUFACTURE.

    Description of Event or Problem · 1

    AN ETHICON ECHELON 60 LINEAR STAPLER WAS USED WITH A BLUE STAPLER LOAD AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (PSD) AT THE GASTRO-ESOPHAGEAL (GE) JUNCTION. THERE WAS NO BLEEDING NOTED FOLLOWING STAPLER FIRING. NO LEAK TEST WAS PERFORMED FOR LEAKAGE INTRAOPERATIVELY. FOLLOWING THE PROCEDURE, THE PATIENT SUFFERED VOMITING OF PSDV BUTTRESS MATERIAL. A LEAK WAS CLINICALLY APPARENT ON THE 5TH POST-OPERATIVE DAY AND IDENTIFIED VIA CT SCAN WITH PER OS CONTRAST MATERIAL. THE LEAK WAS MANAGED CONSERVATIVELY WITH DRAINAGE UNDER CT GUIDANCE AND FINALLY WITH STENT PLACEMENT. IN THE PHYSICIAN'S OPINION, THE PATIENT'S VOMITING WAS ATTRIBUTED TO THE ONGOING INTRA-ABDOMINAL INFLAMMATION. MOST PROBABLY ISCHEMIA WAS THE ETIOLOGY OF THE LEAK AT THE GASTROESOPHAGEAL JUNCTION. CURRENTLY, THE PATIENT IS ASYMPTOMATIC AND IS SCHEDULED FOR STENT REMOVAL IN THE NEAR FUTURE. NOTE: SAME PROBLEM AND REPORTER AS MANUFACTURER REPORT NUMBER 2183620-2010-00058, AS TWO DEVICES WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT STAPLE LINE BUTTRESS FTM SYNOVIS SURGICAL INNOVATIONS PSD 6002 ECH 5754703-1073901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention