BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREPOINT LASER

    MDR report key: 6095439 · Received November 11, 2016

    Report

    Report Number
    2028159-2016-05127
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT FIRING THE LASER PRESENTED A LOW INTENSITY. NO INFORMATION WAS GIVEN ABOUT ANESTHESIA. NO PATIENT IDENTIFIERS WERE NOTED. THE SYSTEM DID NOT DISPLAY ANY SYSTEM MESSAGE. THE DIRECTIONS FOR USE (DFU) WERE FOLLOWED. THE PATIENT HAD A HEMORRHAGE. THE PROCEDURE WAS ABORTED AND WILL BE RESCHEDULED AFTER THE SYSTEM HAS BEEN FIXED. ADDITIONAL INFORMATION WAS REQUESTED WITH NONE RECEIVED TO DATE. THE OPERATORS MANUAL INCLUDES A WARNING: SINCE THE AIMING BEAM PASSES DOWN THE SAME DELIVERY SYSTEM AS THE TREATMENT BEAM, IT PROVIDES A GOOD METHOD OF CHECKING THE INTEGRITY OF THE DELIVERY SYSTEM. IF THE AIMING BEAM SPOT IS NOT PRESENT AT THE DISTAL END OF THE DELIVERY SYSTEM, OR ITS INTENSITY IS REDUCED OR IT LOOKS DIFFUSED, THIS A POSSIBLE INDICATION OF A DAMAGED OR NOT PROPERLY WORKING DELIVERY SYSTEM. IF THERE IS ANY DOUBT, CONTACT ALCON TECHNICAL SERVICES. THE OPERATORS MANUAL ALSO PROVIDES RECOMMENDATIONS FOR USE: THE POWER KNOB IS USED TO ADJUST THE TREATMENT LASER POWER AND IT FUNCTIONS AS DESCRIBED BELOW: TURNING THE POWER KNOB CLOCKWISE INCREASES THE LASER POWER. TURNING THE POWER KNOB COUNTER-CLOCKWISE DECREASES THE POWER. NO FURTHER INFORMATION WAS RECEIVED REGARDING THE LASER POWER SETTINGS. THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS REPLICATED. LOW INTENSITY WAS CONFIRMED. THE COMPANY REPRESENTATIVE CALIBRATED THE LASER, REPOSITIONED THE MIRRORS, AND PERFORMED A PREVENTIVE MAINTENANCE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED LOW LASER POWER CAN BE ATTRIBUTED TO THE LASER BEING OUT OF CALIBRATION. HOWEVER, HOW OR WHEN THIS BECAME NONCONFORMING, CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT FIRING THE LASER PRESENTED A LOW INTENSITY. NO INFORMATION WAS GIVEN ABOUT ANESTHESIA. NO PATIENT IDENTIFIERS WERE NOTED. THE SYSTEM DID NOT DISPLAY ANY SYSTEM MESSAGE. THE DIRECTIONS FOR USE (DFU) WERE FOLLOWED. THE PATIENT HAD A HEMORRHAGE. THE PROCEDURE WAS ABORTED AND WILL BE RESCHEDULED AFTER THE SYSTEM HAS BEEN FIXED. ADDITIONAL INFORMATION WAS REQUESTED WITH NONE RECEIVED TO DATE. THE OPERATORS MANUAL INCLUDES A WARNING: SINCE THE AIMING BEAM PASSES DOWN THE SAME DELIVERY SYSTEM AS THE TREATMENT BEAM, IT PROVIDES A GOOD METHOD OF CHECKING THE INTEGRITY OF THE DELIVERY SYSTEM. IF THE AIMING BEAM SPOT IS NOT PRESENT AT THE DISTAL END OF THE DELIVERY SYSTEM, OR ITS INTENSITY IS REDUCED OR IT LOOKS DIFFUSED, THIS A POSSIBLE INDICATION OF A DAMAGED OR NOT PROPERLY WORKING DELIVERY SYSTEM. IF THERE IS ANY DOUBT, CONTACT MANUFACTURER TECHNICAL SERVICES. THE OPERATORS MANUAL ALSO PROVIDES RECOMMENDATIONS FOR USE: THE POWER KNOB IS USED TO ADJUST THE TREATMENT LASER POWER AND IT FUNCTIONS AS DESCRIBED BELOW: TURNING THE POWER KNOB CLOCKWISE INCREASES THE LASER POWER. TURNING THE POWER KNOB COUNTER-CLOCKWISE DECREASES THE POWER. NO FURTHER INFORMATION WAS RECEIVED REGARDING THE LASER POWER SETTINGS. THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS REPLICATED. LOW INTENSITY WAS CONFIRMED. THE COMPANY REPRESENTATIVE CALIBRATED THE LASER, REPOSITIONED THE MIRRORS, AND PERFORMED A PREVENTIVE MAINTENANCE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED ¿LOW LASER POWER¿ CAN BE ATTRIBUTED TO THE LASER BEING OUT OF CALIBRATION. HOWEVER, HOW OR WHEN THIS BECAME NONCONFORMING, CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    A MAINTENANCE ASSISTANT REPORTED THAT DURING A PHOTOCOAGULATION PROCEDURE THE LASER PRESENTED WITH LOW LASER INTENSITY. THE PATIENT EXPERIENCED A HEMORRHAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748002 PUREPOINT LASER LASER, OPHTHALMIC HQF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other