BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SBT 10MM

    MDR report key: 270620 · Received March 21, 2000

    Report

    Report Number
    1626598-2000-00017
    Event Type
    Malfunction
    Date Received
    March 21, 2000
    Report Date
    February 25, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    DRC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE BALLOON BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SBT 10MM 10MM SBT (STRUCTURAL BALLOON TROCAR) DRC UNITED STATES SURGICAL CORPORATION OMS-T10SB 0410991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN