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

Model Number	EC-5000 QUEST
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	03/04/2016
Additional Manufacturer Narrative
In regards to the patient injury complaint, nidek clinical specialist and customer service manager contacted facility on (b)(4) 2016 to gather additional information.A representative ((b)(6)) from (b)(6) office called back and informed that doctor is aware of the issue occurred with this patient.He also assured that the problem is not related to "nidek's product".However the problem is related to the keratome (zeimer femto laser) used by sharpe vision.As per the information from nidek field service representative, dr (b)(6) uses ziemer femto laser.After the investigation nidek would like to confirm that the patient injury occurred is due to the keratome (zeimer femto laser) and not the nidek inc.'s ec-5000 quest.Since the device in question is not manufactured by nidek inc., additional information regarding device evaluation is not available.Additionally, other information related to the status of the patient injury, any medical or surgical intervention was required or not was not provided by the patient and/or the user facility at the time.
Event or Problem Description
Nidek inc.Customer service representative (rep.) received a call on (b)(4) 2016 from gentlemen by the name of (b)(6) complaining that his girlfriend received lasik from dr (b)(6) on (b)(6) 2016.Patient reported that during surgery, she had a major damage on one eye.As per the reporter, dr (b)(6) informed that the laser made a "j cut" causing damage to the patient's eye (eye lid).However, nidek customer service rep.Informed (b)(6) that nidek laser does not perform the cut and that there is a different piece of equipment that does that portion.(b)(6) also mentioned that on (b)(6) 2016 patient received prk from dr (b)(6) on the other eye.

• Brand Name: EC-5000 QUEST
• Common Device Name: NIDEK EXCIMER LASER QUEST
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• MDR Report Key: 5618524
• Report Number: 3002807715-2016-00016
• Device Sequence Number: 18834390
• Product Code: HQF
• UDI-Device Identifier: 04987669100028
• UDI-Public: (01)04987669100028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EC-5000 QUEST
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• Initial Report FDA Received Date: 04/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1