BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE MULTIVAC 50XL

    MDR report key: 4128496 · Received September 23, 2014

    Report

    Report Number
    MW5038363
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ARTHROCARE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT: ARTHROCARE MULTIVAC 50XL MFG. BY: ARTHROCARE, LOT NO: 1073296, PRODUCT CATALOG #: ASC4730-01. DISTRIBUTED BY: ARTHROCARE THE SMALL BLACK PORTION OF THE TIP OF THE WAND CAME OFF INSIDE THE PT. IT WAS ABLE TO BE VISUALIZE UNDER XRAY, BUT COULD NOT BE RETRIEVED AFTER NUMBEROUS ATTEMPTS. IT IS A RETAINED FOREIGN BODY. DIAGNOSIS OR REASON FOR USE: ARTHROSCOPY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590868 ARTHROCARE MULTIVAC 50XL ARTHROCARE MULTIVAC 50XL GEI ARTHROCARE ARTHROCARE MULTIVAC 50XL 1073296

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other