RT-5100
Received Jul 14, 2017 · Event occurred Jun 30, 2017
Report 0002936921-2017-00018 · MDR key 6716341
Device
Generic name
Refractor
Manufacturer
Nidek Co., Ltd.Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
28 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 (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.
Remedial action
- Recall