BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTILITE SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6089909 · Received November 9, 2016

    Report

    Report Number
    1820334-2016-01275
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 15, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002485266
    PMA / PMN Number
    K073496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. MANUFACTURER REPORT # - THE IS A RESUBMISSION OF A FOLLOW UP ALREADY SENT, DUE TO A PREVIOUSLY INVALID MANUFACTURER REPORT NUMBER (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD, DOCUMENTATION, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(6). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    A CYSTOSCOPY, RHP, LEFT PYELOSCOPY LASER STONES AND 1/0 STENT PROCEDURE WAS BEING CONDUCTED ON THE (B)(6) MALE PATIENT WITH RECURRING LEFT RENAL STONES. DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE LASER WAS NOT WORKING. THE LASER WAS TAKEN OUT OF THE SCOPE AND FIBER OUTSIDE AND IT WAS NOTICED THAT THE LASER FIBER HAD SNAPPED. THE USER HAD TO REMOVE THE BROKEN PIECE THROUGH THE BASKET FROM THE KIDNEY. (IT WAS NOTICED THAT THE UTEROSCOPE DID DAMAGE) THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740044 OPTILITE SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A 00827002485266

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention