BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYTEC SPONGES

    MDR report key: 4699473 · Received April 13, 2015

    Report

    Report Number
    MW5042102
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    March 30, 2015
    Report Date
    April 2, 2015
    Manufacturer
    RF SURGICAL SYSTEMS, INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELEVEN RAYTEC SPONGES PRESENT IN GYN LAP PACK INSTEAD OF THE USUAL/STANDARD NUMBER OF 10. SPONGES ARE PROVIDED BY (B)(4). TO BE USED IN GYN LAPAROSCOPY PACKS CHS WHICH ARE ASSEMBLED BY MEDLINE INDUSTRIES, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246288 RAYTEC SPONGES RAYTEC SPONGES GDY RF SURGICAL SYSTEMS, INC. CMPJ02413B 14WB0292
    246289 LAPAROSCOPY PACK LAPAROSCOPY PACK LRO MEDLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other