BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSI STERI SET

    MDR report key: 852247 · Received April 23, 2007

    Report

    Report Number
    MW5001874
    Event Type
    Malfunction
    Date Received
    April 23, 2007
    Date of Event
    April 2, 2007
    Report Date
    April 23, 2007
    Manufacturer
    MEDICAL STERILIZATION INC.
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A C-SECTION, UPON OPENING THE PERITONEUM, IT WAS NOTED THAT ONE OF THE BLADES OF A METZENBAUM SCISSOR BROKE OFF AND FELL ABOVE THE PERITONEAL AREA. BOTH BLADE AND SCISSOR WAS REMOVED OFF THE FIELD. ALL PIECES RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MSI STERI SET METZENBAUM SCISSOR LRW MEDICAL STERILIZATION INC. S6265 20021

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR