BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION LAPAROSCOPIC SCISSOR TIP

    MDR report key: 9763674 · Received February 26, 2020

    Report

    Report Number
    MW5093322
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 11, 2020
    Manufacturer
    CAREFUSION 2200, INC. / BD
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE PIECE OF A CAREFUSION BRAND DISPOSABLE LAPAROSCOPIC SCISSOR TIP WAS LEFT IN A REUSABLE SCISSOR HANDLE AND HANDLE WAS PROCESSED IN A LAP CHOLE SET ON (B)(6) 2020. ON (B)(6) 2020 THE LAP CHOLE SET WAS OPENED FOR A CASE IN ROOM 1 AND THE DEFECTIVE PRODUCT NUMBER: SP95. PRODUCT DESCRIPTION: NON-RATCHETED HANDLE. LOT NUMBER: UNK. QUANTITY: 1. BD COMPLAINT: PR (B)(4). THE BD REP HAS REPORTED THE REUSABLE SCISSOR HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220631 CAREFUSION LAPAROSCOPIC SCISSOR TIP ELECTROSURGICAL CUTTING AND COAGULATION GEI CAREFUSION 2200, INC. / BD

    Patients

    Seq Age Sex Outcome Treatment
    1