MAUDE Adverse Event Report: NIDEK CO., LTD. RT-5100; REFRACTOR

Device Problem Detachment Of Device Component (1104)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

No serious injury occurred and no known impact or consequence to the doctor involved.However, nidek incorporated considers this issue a reportable event as the device had malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur.Nidek inc.Is aware of this issue and corrective action has been implemented under recall z-1245-2016.Nidek hired a third party (b)(4) to performed the correction as per z-1245-2016.

Event Description

On (b)(6) 2017, during recall process, a nidek incorporated recall coordinator received information from a customer that the near point chart rod on their rt-5100 serial #(b)(4) fell several times and had hit her and another employee on the head on multiple occasions.The complainant claimed that no bruise or no serious injury occurred, and thereby, medical treatment/intervention was unnecessary.

• Brand Name: RT-5100
• Type of Device: REFRACTOR
• Manufacturer (Section D): NIDEK CO., LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer (Section G): NIDEK CO., LTD.; 34-14 hiroishi; 443-0 038; JA 443-0038
• Manufacturer Contact: preeti bhatia ; 47651 westinghouse drive; fremont, CA 94539-7474 ; 8002239044
• MDR Report Key: 6715999
• MDR Text Key: 80145466
• Report Number: 0002936921-2017-00015
• Device Sequence Number: 1
• Product Code: HKN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1245-2016
• Patient Sequence Number: 1
• Patient Age: 55 YR