BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "REFLEX" ELC

    MDR report key: 278131 · Received May 15, 2000

    Report

    Report Number
    278131
    Event Type
    Injury
    Date Received
    May 15, 2000
    Date of Event
    May 8, 2000
    Report Date
    May 12, 2000
    Manufacturer
    RICHARD - ALLAN MEDICAL INDUSTRIAL
    Product Code
    GDO
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPIC CLIP APPLIER FAILED TO FIRE WHEN ATTEMPTING TO LIGATE THE CYSTIC DUCT DURING A LAPAROSCOPIC CHOLECYSTECTOMY. AT THE POINT OF MISFIRE, CYSTIC DUCT WAS SEVERED. CLIP APPLIER ALSO FAILED TO FIRE IN 3 OTHER ATTEMPTS DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "REFLEX" ELC DISPOSABLE ENDOSCOPIC CLIP APPLIER GDO RICHARD - ALLAN MEDICAL INDUSTRIAL 530 (MEDIUM-LARGE) 08K99

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R