BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE HOLMIUM FIBER

    MDR report key: 2061301 · Received April 7, 2011

    Report

    Report Number
    MW5020265
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 6, 2011
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN LATE MARCH, EITHER DR (B)(6) (UROLOGIST) AT (B)(6) MEDICAL CENTER IN (B)(6) HAD A BLUE HOLMIUM FIBER PROVIDED BY FOR TEC MEDICAL, WITH KNOWN FRACTURE RELATED PROBLEMS, HAD A PIECE BREAK OFF AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FRAGMENT THAT BROKE OFF DURING THE PROCEDURE. (B)(6) MEDICAL OF (B)(6) REPROCESSES SINGLE USE HOLMIUM FIBERS AND TO BEST OF MY KNOWLEDGE OBTAINED BY CONTACTING THE FDA DOES NOT HAVE FDA APPROVAL TO PROVIDE REPROCESSED FIBERS. AN INCIDENT REPORT WAS COMPLETED BY THE (B)(6) TECHNICIAN AND TURNED IN TO THE SALESMAN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE HOLMIUM FIBER NONE GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other