MAUDE Adverse Event Report: NIDEK CO., LTD. US-500; ULTRASONIC ECHOSCAN

Model Number US-500

Device Problem Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

As a result of investigation, due to the fact that the device was not returned, we performed a test to verify the similar symptom of abnormal measurement.The measured result of model eye for test: 24.72mm.The measured result when "gate on" function, and there is 2 to 3mm clearance from the model eye contacted part: 27.40mm.We observed 2.68mm difference in measured value.When axial length gets longer, even though there is noise during "gate on" function, because of tear and topical anesthesia eye-drops, it was measured with clearance from the cornea.It is determined that the cause of this incident was user's operational error.This event was occurred at the facility in (b)(6), however; same product model was distributed in u.S and therefore we determined this information was reportable.At this moment, we did not obtain the information that medical intervention was performed after this surgery.We will submit a follow-up report as soon as possible when additional information is obtained.

Event Description

There is no problem when measuring model eyes, but there is a problem when measuring human eyes.The doctor inserted improper lenses (4-6d difference) to several patients.

Manufacturer Narrative

The unit was returned, and we have performed re-investigation.We checked the unit.There was no measured data of patients inside the unit even though the unit is set to save measured data to incide the unit.We checked performance of the unit.The unit passed the inspection, and no defect was found.We requested patient's raw data to the foreign distributor, but we did not receive information.Conclusion: no patient data inside the unit.We received information of the symptom, but when we request the raw data of the patient, the doctor loses in touch with us, therefore; we determined that information of this complaint is not reliable.Due to the fact that no defect were found from the device, it is determined that this is user's operational error.This incident was caused by the user's operational error.

Event Description

See initial mdr 0008030392-2017-00002 for details.

• Brand Name: US-500
• Type of Device: ULTRASONIC ECHOSCAN
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 maehama, hiroishi-cho; gamagori, aichi 44300 38; JA 4430038
• Manufacturer Contact: noriyuki yamaguchi ; 34-14 maehama, hiroishi-cho; gamagori, aichi 44300-38 ; JA 4430038
• MDR Report Key: 6745951
• MDR Text Key: 81113089
• Report Number: 8030392-2017-00002
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: US-500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention