BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYC-1000

    MDR report key: 5911819 · Received August 29, 2016

    Report

    Report Number
    3002807715-2016-00034
    Event Type
    Injury
    Date Received
    August 29, 2016
    Date of Event
    August 1, 2016
    Report Date
    September 6, 2016
    Manufacturer
    NIDEK CO, LTD.
    Product Code
    HQF
    PMA / PMN Number
    K032085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP REPORT WAS SUBMITTED UNDER 0002936921-2016-00001 ON OCT 3, 21016. THIS REPORT SUPERSEDES IT DUE TO THE CONFLICT IN THE NUMBERING. MEDWATCH FOLLOW-UP REPORT IS BEING SUBMITTED TO THE FDA TO CLARIFY AND/OR CORRECT THE INFORMATION INITIALLY PRESENTED IN THE MDR REPORT SUBMITTED ON 8/29/2016 UNDER MFR NUMBER: 3002807715-2016-00034. ON 9/6/2016, NIDEK INC HAS LEARNED THAT AN INADVERTENT (ACCIDENTAL) OMISSION OF PATIENT CODE, AS IT APPLIED TO THIS REPORT HAD NOT BEEN INCLUDED. PLEASE NOTE THAT PATIENT CODE, AS IT RELATES TO CORNEAL BURN, IS APPLICABLE TO THIS REPORT, AS A DIRECT RESULT OF THE BURNED CORNEA EXPERIENCED BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN QUESTION WAS NOT RETURNED TO NIDEK INC FOR EVALUATION; HOWEVER, A NIDEK INC FIELD SERVICE ENGINEER (FSE) HAD BEEN DISPATCHED TO CONDUCT AN ONSITE SERVICE EVALUATION. ON 8/11/2016, FSE ARRIVED AT THE SITE WHERE A PHYSICIAN AT THE CLINIC, DR. (B)(6) HAD INFORMED HIM THAT A FOLLOW-UP WAS MADE WITH THE PATIENT; WHERE THE MALE PATIENT WAS SAID TO BE IN GOOD CONDITION. THERE WAS NO ADDITIONAL TREATMENT NECESSARY. THE LASER ENERGY CALIBRATION WAS TESTED IN ACCORDANCE TO THE GYC-1000 PREVENTIVE MAINTENANCE CHECKLIST, SPECIFICALLY AT THE REPORTED POWER OF 1000MW INDICATED DURING THE PATIENT TREATMENT. DURING THE TEST, THE LASER OUTPUT WAS MEASURED TO BE 1081MW OUT OF ITS DELIVERY AT 1000M, WHICH IS WELL WITHIN THE 15% SPECIFICATION REQUIREMENTS ALLOWED. THE DELIVERY WAS IN FOCUS AT BOTH 50UM AND 200UM WHILE THE TREATMENT BEAM WAS PARFOCAL WITH THE FOCAL PLANE AS PER THE SPECIFICATIONS. ADDITIONALLY, FE OBSERVED THE CONDENSER LENS TO BE CLEANED FOLLOWING ITS REMOVAL. THE DELIVERY MIRROR AND OPTICS WERE ALSO FOUND TO BE CLEANED. THE FIBER XY STAGE WAS ALSO RE-CENTERED AS A RESULT OF THE CONDENSER LENS REMOVAL DURING INSPECTION. THE FIBER OUTPUT POWER WAS RETESTED AND FOUND TO BE WITHIN SPECIFICATIONS. FE HAD CONCLUDED THAT THE LASER SYSTEM WAS IN GOOD WORKING CONDITION, WHICH DID NOT CAUSE AND/OR CONTRIBUTE TO THE REPORTED EVENT. ON 8/11/2016, QUALITY ENGINEER VERBALLY DISCUSSED THE REPORTED EVENT WITH THE USER FACILITY. BASED ON THE CLINICAL DIRECTOR/ADMINISTRATOR ACCOUNTS, THE DR. HAD HIT (LASER BEAM) THE MALE PATIENT'S DARK CORNEA WITH 1000MJ WHEREAS FSE HAD ADVISED THE SITE DURING THE ONSITE EVALUATION TO INCREASE THE ENERGY INCREMENTALLY UNTIL THE DESIRED EFFECT IS REACHED. FOLLOWING THE FLASH OBSERVED, THE PROCEDURE WAS STOPPED AND UPON EXAMINING THE PATIENT'S EYE, A BURNED CORNEA EPITHELIAL ON THE RIGHT EYE WAS NOTED. THE PATIENT WAS GIVEN PROPHYLACTICS FOR A WEEK. THE PATIENT IS REPORTEDLY DOING FINE. THERE ARE NO FURTHER MEDICAL TREATMENT REQUIRED. THE PATIENT IS SCHEDULED TO RETURN BACK TO THE CLINIC TO COMPLETE THE INTENDED PROCEDURE. ACCORDING TO THE CLINICAL DIRECTOR/ADMINISTRATOR, THERE WERE NO ABNORMALITIES OBSERVED WITH THE DEVICE PRIOR TO USE. ADDITIONALLY, THE DR WAS NOT NEW IN PRACTICE AND HAS BEEN PRACTICING FOR 2 YEARS WITH FULL DEVICE TRAINING OBSERVED PRIOR TO USE. IT WAS REPORTED THAT THE SAME DR HAD PERFORMED SIMILAR CASES IN THE PAST WHERE NO ADVERSE RELATED EVENTS HAD OCCURRED. ALTHOUGH THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION DURING THE COURSE OF ITS INVESTIGATION, NIDEK INC IS SUBMITTING A MEDWATCH REPORT AS A RESULT OF THE PATIENT ADVERSE-RELATED INCIDENT.

    Description of Event or Problem · 1

    SEE INITIAL MDR-3002807715-2016-00034 REPORT FOR DETAILS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, NIDEK INC SALES TERRITORY MANAGER RECEIVED A TELEPHONE CALL FROM A CUSTOMER COMPLAINING THAT THEY HAD AN ISSUE WITH THE GREEN LASER; HOWEVER NO SPECIFIED ISSUE WAS PRESENTED EVEN AFTER A FOLLOW-UP CALL WAS MADE BY A NIDEK INC SERVICE MANAGER. ON (B)(6) 2016, (B)(6), PC RETURN THE CALL TO REPORT THAT ONE OF THE DOCTORS AT THE OFFICE WAS PERFORMING A PERIPHERAL IRIDECTOMY ON A PATIENT WHERE THE PATIENT SUFFERED A BURN ON THE CORNEA EPITHELIAL. A DIFFERENT DOCTOR HAD REPORTEDLY TESTED THE LASER ON A PAPER THE NEXT DAY AND FOUND THE SYSTEM TO BE OPERATIONAL. THE LASER HAS NOT BEEN USED SINCE THIS INCIDENT. A NIDEK INC FIELD SERVICE ENGINEER HAD FOLLOWED UP WITH (B)(6) WHEREAS TOLD, SHE BELIEVED THE DOCTOR HAD USED TOO MUCH POWER. SHE ALSO MENTIONED THAT THE DOCTOR HAD NOT USED THE LENS. THE PATIENT WAS REPORTEDLY GIVEN PROPHYLACTICS FOR A WEEK. THE PATIENT IS DOING FINE TO DATE. THE PROCEDURE HAS BEEN RESCHEDULED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563606 GYC-1000 GREEN LASER PHOTOCOAGULATOR HQF NIDEK CO, LTD. GYC-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention