MAUDE Adverse Event Report: NIDEK CO. LTD. EC-5000 QUEST; EXCIMER LASER

Model Number	EC-5000 QUEST
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A nidek inc.Field service engineer (fse) evaluated the device at customer's site on (b)(4) 2018.Fse powered on the system and found it in working order.Fse found the aiming beam to be off-center.The ablation was off very minimally (about 0.01) barely noticeable through the microscope by the fse.A red aiming laser beam is emitted from the objective lens of the microscope, allowing the physician to align the beam with the cross-shaped aperture.As per the technical manager expert analysis, the aiming beam drifting out of its position could cause off-centered ablation.The aiming beam has to be aligned at the vertex of model eye, and ablation is to be performed after confirming the center of reticle illumination, aiming beam, and laser optical axis are aligned.Per ec-5000 quest service manual, adjustment can be made to the g10 mirror assy.(26202-2350) so the burn pattern comes in the center of alignment illumination.Thereby, fse re-aligned the g-10 optic to center.The aiming beam and the eye tracker were checked after the re-alignment and found to be proper.The laser calibration was performed referring to section 5.3 of the ec-5000 quest operator's manual for the setting: normal 132mj flex scan 127mj hyperopia 48.0 seconds the customer reported issue was resolved, no problem was found after the g10 mirror adjustment made.Fse confirmed that the device operated within specifications.The customer reported issue was due to g-10 optics out of alignment.Per ec-5000 quest operator's manual, calibration of laser is required prior to beginning first surgery case.The system does not allow the physician to perform the surgery unless the ablation rate is calibrated.It is also recommended to calibrate after every 4th surgery.
Event or Problem Description
On (b)(6) 2018, nidek inc.Customer service received a telephone call from the user facility to report that the ablation was off-center on the ec-5000 quest serial # (b)(4).There was no injury reported by the user facility and they had requested service.On january 15 2019, it was confirmed by the doctor that he observed the issue while checking the ablation during a routine calibration on the device.There is no adverse event or injury occured so no patient information is available.Decentered ablation is an infrequent complication of laser eye surgery that occurs when the treatment is not properly centered over the pupil.Laser ablations that are off-center by as little as 0.5mm can cause visual symptoms, including glare and halos, ghost images, and blurred vision.Per ec-5000 quest operator's manual, the operator must make sure to calibrate the ablation rate before the actual surgery.The system does not allow surgery to be performed unless the ablation rate is calibrated.Although no patient injury occurred, nidek inc.Considers ablation off-center on the excimer laser as a reportable event, as there could be potential adverse impact to the patient if the event was to recur.

• Brand Name: EC-5000 QUEST
• Common Device Name: EXCIMER LASER
• Manufacturer (Section D): NIDEK CO. LTD.; 34-14 hiroshi; gamagori, aichi 443-0 038; JA 443-0038
• MDR Report Key: 8249410
• Report Number: 0002936921-2018-00012
• Device Sequence Number: 16691851
• Product Code: LZS
• UDI-Device Identifier: 04987669100028
• UDI-Public: (01)04987669100028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P970053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: EC-5000 QUEST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1