BEUDAMED
    FDA Adverse Event Summary report: N

    GELPORT SYSTEM WITH ALEXIS RETRACTOR 120MM

    MDR report key: 2484957 · Received February 27, 2012

    Report

    Report Number
    2027111-2012-00048
    Date Received
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE RESPONDING IN RECEIPT OF THE MEDWATCH REPORT # (B)(4). INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVAL. UPON INSPECTION ENGINEERING FOUND A TEAR AND A PUNCTURE ON THE SHEATH. THE TEAR APPEARED CLEAN, AS IF CAUSED BY SCISSORS OR A SHARP INSTRUMENT. THE PUNCTURE APPEARS TO HAVE BEEN CAUSED BY A FINGERNAIL. VISUAL INSPECTION IS PERFORMED 100% ON ALL GELPORT AND ALEXIS WOUND RETRACTORS DURING THE MFG AND ASSEMBLY PROCESS. A REVIEW OF THE MFG RECORDS FOR THIS LOT CONFIRMED THAT THE PRODUCT PASSED ALL MFG AND QUALITY INSPECTIONS. THIS DOCUMENT REPRESENTS OUR INITIAL /FINAL REPORT.

    Description of Event or Problem · 1

    CER SUBMITTED: LAPAROSCOPIC LEFT COLECTOMY ¿ ¿RIPPED BEFORE TOP SEALER WAS APPLIED.¿ MEDWATCH REPORTED: ¿GEL SEAL RIPPED BEFORE APPLICATION. THE SEAL REMOVED FROM FIELD, REPLACED WITH ANOTHER PRODUCT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT SYSTEM WITH ALEXIS RETRACTOR 120MM GELPORT SYSTEM GAD APPLIED MEDICAL RESOURCES CORP. C8XX2 1158395

    Patients

    Seq Age Sex Outcome Treatment
    1