BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNOVIS SURGICAL INNOVATION

    MDR report key: 515382 · Received February 25, 2004

    Report

    Report Number
    MW1031330
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    February 18, 2004
    Report Date
    February 24, 2004
    Manufacturer
    SYNOVIS LIFE TECHNOLOGIES
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING "PERI STRIPS DRY" TO STERILE FIELD, 2 PACKAGES WERE OFF CENTER (MAL-ALIGNED) PREVENTING, PROPER LOADING OF STRIPS TO SURGICAL STAPLER. PERI STRIPS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNOVIS SURGICAL INNOVATION STAPLE LINE REINFORCEMENT FTL SYNOVIS LIFE TECHNOLOGIES * 558211
    2 SYNOVIS SURGICAL INNOVATION STAPLE LINE REINFORCEMENT FTL SYNOVIS LIFE TECHNOLOGIES * 558211

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other