BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

    MDR report key: 2223852 · Received August 18, 2011

    Report

    Report Number
    2183620-2011-00064
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    PMA / PMN Number
    K040415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN ARTICLE REPORTED A PROSPECTIVE COMPARATIVE STUDY OF ALL PTS WHO UNDERWENT LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) BY A STANDARD SURGICAL TEAM IN AN 18-MONTH PERIOD. IN TOTAL 187 PTS, WITH A MEDIAN PREOPERATIVE BMI OF (B)(6), UNDERWENT LSG. GROUP A HAD PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (PSD) REINFORCED STAPLE LINES AND ENROLLED 96 PTS. GROUP B DID NOT HAVE STAPLE LINE REINFORCEMENT AND ENROLLED 91 PTS. IT WAS NOTED THAT ONE PT WITH PSD EXPERIENCED A TYPICAL LEAK IN THE UPPER THIRD OF THE GASTRIC TUBE LOCATED IN THE UPPER GI SERIES. NO FURTHER DETAILS WERE PROVIDED. THE ARTICLE REPORTS THAT THE "REINFORCEMENT OF THE STAPLE LINE IN LSG RESULTED IN SIGNIFICANTLY FEWER SURGICAL COMPLICATIONS COMPARED TO STANDARD STAPLING OF THE GASTRIC TUBE," WHICH ALSO INCLUDES A "REDUCTION IN THE LENGTH OF HOSPITALIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERI-STRIPS DRY STAPLE LINE REINFORCEMENT STAPLE LINE BUTTRESS DXZ SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention