1.RT-5100
Received Aug 31, 2017 · Event occurred Aug 18, 2017
Report 0002936921-2017-00021 · MDR key 6835428
Device
Generic name
Refractor
Manufacturer
Nidek Co., Ltd.Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
60 YR
- No Known Impact Or Consequence To Patient
- No Code Available
- No Known Impact Or Consequence To Patient
- No Code Available
Narrative
Additional 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 PERFORM THE CORRECTION AS PER Z-1245-2016.
Description of Event or Problem
ON AUGUST 18, 2017, NIDEK INC. DISTRIBUTOR SALES MANAGER RECEIVED AN EMAIL FROM THE DIRECTOR OF CUSTOMER CARE FROM (B)(6) THAT A CUSTOMER (WHOM IS A DOCTOR) WAS UPSET THAT THE NEAR POINT CHART ROD ON THEIR RT-5100 FELL SEVERAL TIMES AND HAD HIT HIM ON THE HEAD ON MULTIPLE OCCASIONS. THE DOCTOR HAS REQUESTED A SERVICE REPAIR. THE COMPLAINANT HAD CONFIRMED THAT NO BRUISE OR NO SERIOUS INJURY OCCURRED, AND THEREBY, MEDICAL TREATMENT/INTERVENTION WAS UNNECESSARY.
Remedial action
- Recall