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.
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Patient 1
ON MAY 24, 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) FALLS AND HAD HIT HER AND TWO DOCTORS IN THE HEAD ON MULTIPLE OCCASIONS WHILE CLEANING OR SETTING UP. THE TECHNICIAN CLAIMED THAT IT WAS NOT A BIG DEAL, OTHER THAN THE INCONVENIENCE AND FURTHERMORE STATED THAT NO SERIOUS INJURIES OCCURRED FROM THE INCIDENT, THEREBY, MEDICAL TREATMENT/INTERVENTION WAS UNNECESSARY.