RT-5100
Received Jul 14, 2017 · Event occurred Jun 28, 2017
Report 0002936921-2017-00014 · MDR key 6715153
Device
Generic name
Refractor
Manufacturer
Nidek Co., Ltd.Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
34 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 HIRED THIRD PARTY (B)(4) TO PERFORM THE CORRECTION AS PER RECALL (Z-1245-2016). AT THIS TIME, DEVICE EVALUATION ANTICIPATED BUT HAS NOT BEGUN. THEREFORE, A FOLLOW-UP WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.
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 DOCTOR ON THE HEAD ON MULTIPLE OCCASIONS. THE COMPLAINANT CLAIMED THAT IT DID HURT FOR A BIT BUT NO BRUISE OR NO SERIOUS INJURY OCCURRED, AND THEREBY, MEDICAL TREATMENT/INTERVENTION WAS UNNECESSARY.
Remedial action
- Recall