BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAYTEC SPONGE, GYN LAP PACK

    MDR report key: 4798052 · Received April 29, 2015

    Report

    Report Number
    3005883396-2015-00002
    Event Type
    Other
    Date Received
    April 29, 2015
    Date of Event
    March 30, 2015
    Report Date
    April 22, 2015
    Manufacturer
    RF SURGICAL SYSTEMS INC
    Product Code
    GDY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    070022000-2014-8005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY REPORTED "11 RAYTEC SPONGES PRESENT IN GYN LAP PACK INSTEAD OF THE USUAL/STANDARD NUMBER OF 10. SPONGES ARE PROVIDED BY RF SURGICAL SYSTEMS, INC TO BE USED IN GYN LAPROSCOPY PACKS CHS WHICH ARE ASSEMBLED BY(B)(6)." THERE WERE NO REPORTED EFFECTS ON PATIENTS ASSOCIATED WITH THE REPORT. STANDARD OPERATING ROOM PROTOCOL REQUIRES MANUAL COUNTING OF SURGICAL SPONGES, AND IN CASES OF INCORRECT COUNTS, SPONGES ARE TYPICALLY REMOVED AND REPLACED. THE REPORTED ISSUE WILL BE MONITORED VIA THE QUALITY MANAGEMENT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY USER FACILITY " EVENT DESC: 11 RAYTEC SPONGES PRESENT IN GYN LAP PACK INSTEAD OF THE USUAL/STANDARD NUMBER OF 10. SPONGES ARE PROVIDED BY RF SURGICAL SYSTEMS, INC TO BE USED IN GYN LAPROSCOPY PACKS CHS WHICH ARE ASSEMBLED BY (B)(6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283608 RAYTEC SPONGE, GYN LAP PACK SURGICAL SPONGE GDY RF SURGICAL SYSTEMS INC CMPJ02413B (REPORTED) 14WB0292 (REPORTED)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA