BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 5784422 · Received July 11, 2016

    Report

    Report Number
    3002807715-2016-00026
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 13, 2016
    Report Date
    September 21, 2016
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HQF
    PMA / PMN Number
    K893987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE YC-1800 YAG LASER SERIAL #(B)(4) WAS RETURNED TO NIDEK CO. (B)(4) FOR FURTHER EVALUATION. NIDEK CO. INVESTIGATION SUMMARY: INSPECTION AND TEST WERE PERFORMED TO VERIFY AND/OR DUPLICATE THE POSSIBLE CAUSES FOR FLASHBACK ISSUE. DURING INSPECTION, THE PROTECTIVE FILTER WAS SECURELY MOUNTED TO THE SLIP LAMP. THE TRANSMITTANCE OF THE PROTECTIVE FILTER WAS MEASURED AND THE RESULT OF TRANSMITTANCE MEASUREMENT OF THE PROTECTIVE FILTER (SPECIFICATION OF TRANSMITTANCE: LESS THAN 0.05%) AT 1,064NM WAS 0.04%. IT WAS CONFIRMED THAT THE RESULT MET THE SPECIFICATION. POWER METER WAS PLACED AT THE OPERATOR'S SIDE OF THE PROTECTIVE FILTER. THE WHITE PAPER SIMULATING THE REFLECTION OF LASER BEAM IN A POSITION SHIFTED ABOUT 1CM FROM YAG LASER FOCAL POINT TOWARD OPERATOR'S SIDE. THE MEASURED POWER OF POWER OF OPERATOR'S SIDE WAS 0.0MJ (LASER SET VALUE: 0.2MJ AND 10.2MJ/POWER METER WAVELENGTH: 1,064NM). THE LASER BEAM WAS EMITTED TO TEST PAPER BURN AT SET VALUE 5.0MJ AND THE LASER BURN PATTERN RESULTED WITH NO PROBLEM. OPERATED THE SYSTEM WITH STANDARD USE AND ELEVATED ANY FLASHBACK THROUGH BINOCULAR OPHTHALMOSCOPE SET TO 5MJ. FLASHBACK WAS NOT DUPLICATED THROUGH BINOCULAR OPHTHALMOSCOPE. NIDEK CO. HAD DETERMINED THAT THE PROBABLE/ROOT CAUSE OF THE FLASHBACK ISSUE WAS INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    IN REGARDS TO THE COMPLAINT FOR FLASHBACK FOR YC-1800 SN: (B)(4). CUSTOMER REPORTED THAT DURING THE USE OF YC-1800, DOCTOR NOTICED FLASHBACK AND LASER HIT THE DOCTORS RETINA. NIDEK INC. MADE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER AND GATHER ADDITIONAL INFORMATION REGARDING THE INCIDENCE. CUSTOMER DID NOT PROVIDE ANY INFORMATION WHETHER THERE WAS ANY ADVERSE EVENT AND/OR ANY INJURY OCCURRED TO THE DOCTOR, ALSO ANY MEDICAL OR SURGICAL INTERVENTION WAS NEEDED OR NOT. THE COMPLAINT OF FLASH BACK COULD NOT BE VERIFIED. AS THE ND: YAG LASER USED IN THE YC-1800 HAS A WAVELENGTH: 1,064 NM AND IT IS INVISIBLE TO HUMAN EYE HENCE POSSIBILITY OF FLASHBACK IS MINIMAL IN THIS CASE. FLASHBACK/LASER EXPOSURE COULD BE SEEN IN FOLLOWING CIRCUMSTANCES: THE YC-1800 IS CLASSIFIED AS A CLASS 3B LASER SYSTEM. A CLASS 3B LASER SYSTEM IS POTENTIALLY HAZARDOUS IF DIRECT OR SCATTERED RADIATION IS VIEWED BY THE UNPROTECTED EYE (INTRABEAM VIEWING), BUT THERE IS NO POSSIBLE HAZARD OF OCULAR INJURIES IF DIFFUSED REFLECTIONS ARE VIEWED. (REFERENCE: OPHTHALMIC YAG LASER SYSTEM; MODEL YC-1800; OPERATOR'S MANUAL §1 INTRODUCTION; 1.4 CLASSIFICATIONS). IN THIS CASE DOCTOR COMPLAINT OF THE FLASH BACK AND NOT THE DIRECT EXPOSURE SO THIS IS NOT THE POSSIBILITY. IN ONE OF THE SCENARIOS IF THERE IS ANY REFLECTIVE OBJECT IN THE OPTICAL PATH BEFORE LASER EMISSION COULD CAUSE THE REFLECTED YAG LASER BEAM. HOWEVER FSE CHECKED THE DEVICE AND DID NOT FIND ANY OUT OF SPECIFICATIONS NEAR THE DEVICE SET UP. (REFERENCE: OPHTHALMIC YAG LASER SYSTEM; MODEL YC-1800; OPERATOR'S MANUAL §2 SAFETY PRECAUTIONS; 2.3 USE). HOWEVER, THERE IS ONE POSSIBILITY THAT WHEN THE YAG LASER PULSE BEAM CONVERGE AT A SPOT, AND THE POWER DENSITY EXCEEDS A CERTAIN DEGREE, PLASMA IS FORMED. SUDDEN EXPANSION AND HEATING OF THE PLASMA GENERATES SHOCK WAVES. THIS PHENOMENON IS CALLED "OPTICAL BREAKDOWN". DOCTOR MIGHT HAVE SEEN THESE THOUGH THE OPTICAL LENS DURING THE TREATMENT WHICH COULD HAVE BEEN CONFUSED WITH THE FLASHBACK. THE FORMED PLASMA ABSORBS AND SCATTERS THE INCIDENT LIGHT HENCE THERE IS NO POSSIBILITY OF THE LASER FLASHBACK .THE POSSIBILITY OF ADVERSE EVENT IS NEGLIGIBLE IN THIS CASE. (REFERENCE: OPHTHALMIC YAG LASER SYSTEM; MODEL YC-1800; OPERATOR'S MANUAL §1 INTRODUCTION, 1.2 PRINCIPLE).

    Description of Event or Problem · 1

    SEE INITIAL MDR 3002807715-2016-00026 SUBMISSION.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2016. CUSTOMER REPORTED THAT DURING THE USE OF YC-1800 SN: (B)(4), DOCTOR NOTICED FLASHBACK. DOCTOR MENTIONED THAT THE LASER SPOT HIT THE PHYSICIAN'S RETINA. NO ADDITIONAL INFORMATION WAS PROVIDED THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437180 YC-1800 YAG LASER HQF NIDEK CO., LTD. YC-1800

    Patients

    Seq Age Sex Outcome Treatment
    1