BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT SURGICAL LASER SYSTEM

    MDR report key: 2571425 · Received May 7, 2012

    Report

    Report Number
    2937094-2012-00437
    Event Type
    Injury
    Date Received
    May 7, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 11, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LASER HAS BEEN SERVICED. MFR SERVICE ENGINEER DISCLOSED THAT THE LASER SYSTEM CONNECTION WAS CHECKED USING A ¿TEST FIBER¿ AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. MFR SERVICE ENGINEER CHECKED THE CONNECTION WITH THE CUSTOMER¿S FIBER AND DID DUPLICATE THE REPORTED ISSUE. MFR SERVICE ENGINEER OBSERVED, DURING THE EVAL OF THE LASER, THAT THE CONNECTION POINTS ON THE LASER SYSTEM HAD A BUILD-UP OF AN UNK SUBSTANCE AND THAT ONCE THE CONTACTS WERE CLEANED THE CONNECTION ISSUE WAS RESOLVED. THE SERVICE REPAIR WAS COMPLETED AND THE LASER WAS RELEASED FOR USE ON (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO PERFORMING A PROCEDURE TO TREAT A BLADDER TUMOR THE LASER SYSTEM WAS UNABLE TO RECOGNIZE THE DEVICE. THE PT WAS TREATED WITH DIRECT VISUAL INTERNAL URETHROTOMY (DVIU). THERE WAS NO REPORT OF A PT INJURY; HOWEVER THE MFR IS FILING THIS AS A DELAY OF CASE AS THE PT UNDERWENT AN UNINTENDED PROCEDURE AS A RESULT OF THE EQUIPMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT SURGICAL LASER SYSTEM LASER SYSTEM GEX AMS INNOVATIVE CENTER-SAN JOSE 0010-0210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SURGICAL FIBER(S)