MAUDE Adverse Event Report: NIDEK CO., LTD. US-4000; ULTRASONIC ECHOSCAN

Model Number US-4000

Device Problem Use of Device Problem (1670)

Patient Problem Blurred Vision (2137)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

In information from a distributor who made contact with the user, at the time of installation, the distributor performed user training such as how to use the equipment.The device was tested by the distributor and confirmed it operated properly.The distributor reported to us that there was inadequate handling by the user, however; we are still waiting for further information from the facility.Therefore, it was considered a possibility that the event was caused by the improper user handling.Although this event occurred in a facility in india, this device is marketed in united state.Nidek determined that it is a reportable event as we became aware of that may have caused or contributed to a serious injury.Follow up report will be submitted when we receive additional information.[(b)(4)].

Event Description

Cataract surgery was performed based on the axial length measured with the nidek eye axial length measuring device (model: us - 4000), and as a result nidek received a report from the distributor that the result was different from the target value.A refractive error (+/- 3.00 ds) occurred after cataract surgery of 15 to 20patients, as a result of the axial length obtained with the highest accuracy of a standard deviation (sd) value 0.03 or less.

Manufacturer Narrative

Abnormal result of axial measurement was reported, and we, nidek submitted initial mdr and concluded that it is due to inadequate user handling based on information from our distributor.In order to provide advice to the user, we tried to contact the user for five times beginning from july 31, 2018; however, we received no responses from the user and we expect no further information would be given from the user.Based on information from our distributor and the investigation at the user facility by a service engineer from our distributor, nidek determined that there was no malfunction in our device.

Event Description

Please see the initial mdr submitted on august 30, 2018.

• Brand Name: US-4000
• Type of Device: ULTRASONIC ECHOSCAN
• Manufacturer (Section D): NIDEK CO., LTD.; noriyuki_yamaguchi@nidek.co.jp; 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: 7831673
• MDR Text Key: 118726339
• Report Number: 8030392-2018-00005
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: US-4000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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