YC-1800
Received Apr 29, 2021 · Event occurred Apr 21, 2021
Report 0002936921-2021-00001 · MDR key 11748164
Device
Generic name
Yag Laser
Model number
YC-1800Product problems
- Unexpected Therapeutic Results
- Insufficient Device Problem Information
- Patient Device Interaction Problem
- Unexpected Therapeutic Results
- Insufficient Device Problem Information
- Patient Device Interaction Problem
Patient
Not reported
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PLEASE SEE THE INITIAL MDR SUBMITTED ON 29-APR-2021.
Additional Manufacturer Narrative
THE YAG LASER, YC-1800 DEVICE S/N (B)(6) WAS EVALUATED BY A NIDEK INC. FIELD SERVICE ENGINEER (FSE) ON 5/26/2021. NIDEK INC. DETERMINED THAT THE PITTING OF IOL WAS INCONCLUSIVE. WHEN FSE TESTED THE LASER FOCUS, THE YAG BEAM WAS PAR-FOCAL WITH THE AIMING BEAM FOCUS. ENERGY WAS MEASURED AT 10MJ AND THE ACTUAL OUTPUT WAS 9.5MJ, WHICH IS WITHIN SPECIFICATION. FSE ADVISED THE DOCTOR TO TRY USING THE FOCUS SHIFT STARTING AT POSTERIOR 250 OFFSET AND THAT THE ENERGY CALIBRATION BEING SLIGHTLY OFF MAY HAVE BEEN A FACTOR. AS REQUESTED FROM THE CUSTOMER, FSE PERFORMED PREVENTIVE MAINTENANCE. WITH TESTING AND INSPECTION, CUSTOMER'S DEVICE WAS VERIFIED AS OPERATIONAL. NIDEK INC. CUSTOMER SERVICE FOLLOWED UP WITH THE DOCTOR ON 5/28/2021. PER DR. (B)(6) , "VISION IS IMPROVED SUBJECTIVELY AND OBJECTIVELY. THE LENS PITTING IS ASYMPTOMATIC. PATIENT IS DOING WELL AT 1 MONTH FOLLOW UP."
Additional Manufacturer Narrative
NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YAG LASER A REPORTABLE EVENT AS THE YC-1800 HAD MALFUNCTION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. AT THIS TIME, EVALUATION ON THE YAG LASER HAS NOT BEGUN, A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION AND REPAIR ARE COMPLETED.
Description of Event or Problem
ON (B)(6) 2021, NIDEK INC. CUSTOMER SERVICE RECEIVED AN EMAIL FROM A DOCTOR TO REPORT THAT HE IS FEELING LIKE THE DEPTH IS OFF ON THE AIMING BEAM. HE'S NOT GETTING THE "TAKES" ON THE LASER WHEN HE SHOULD BE (MEANING THERE IS NO TISSUE RESPONSE TO THE LASER EMISSION), AND HE ALSO REPORTS GETTING PITTING WHEN IT SHOULD NOT BE OCCURRING. THE ISSUE OCCURRED WHILE USING THE YC-1800 DEVICE S/N (B)(4) IN THE FACILITY'S LASER ROOM. ACCORDING TO THE DOCTOR, THE PITTING LENS OCCURRED ON (B)(4) 2021, BUT HE HAD OCCASIONAL PITTING SINCE HE STARTED USING THE LASER IN (B)(6) 2020. THE CURRENT CONDITION OF THE PATIENT IS FINE, AND HE IS PENDING FOLLOW-UP IN A COUPLE OF WEEKS. PER DOCTOR, PITTING LENS DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO BODY STRUCTURE. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUES WERE TO RECUR.