BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RT-5100 REFRACTOR

    MDR report key: 3834571 · Received May 2, 2014

    Report

    Report Number
    3002807715-2014-00001
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Removal / Correction Number
    2936921-4/17/2014-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK INC. WAS UNDER FDA INSPECTION FROM (B)(4) 2014. NIDEK INC. WAS PREPARING A CORRECTION REPORT TO FDA AND HAD AN OPPORTUNITY TO DISCUSS ON OUR CORRECTION STRATEGY WITH FDA (B)(4). DURING A TELECONFERENCE WITH THEM ON (B)(4), NIDEK INC. WAS ADVISED BY A DR IN (B)(4) THAT A COMPLAINT RELATING LACERATION OF THE NOSE WAS A SERIOUS INJURY AS SHE SAID "I DON'T THINK THE FIRMS' ANALYSIS OR STRATEGY IS APPROPRIATE. I WOULD CONSIDER ANY INJURY TO THE FACE THAT CAN CAUSE SCARRING A SERIOUS INJURY AND IT IS REPORTABLE." NIDEK INC. AND NIDEK CO., LTD. DETERMINED TO SUBMIT EACH MDR TO FDA BASED ON THE ADVICE FROM (B)(4). WE SINCERELY APOLOGIZE WE DID NOT SUBMIT THIS MDR WITHIN 30 CALENDAR DAYS. ON THE OTHER HAND, OUR CORRECTION STRATEGY IN THE DRAFT OF CUSTOMER NOTIFICATION LETTER WAS ACCEPTED BY ALL FDA ATTENDEES IN THE TELECONFERENCE ON (B)(4). OUT STRATEGY IS TO PROVIDE PREVENTIVE MAINTENANCE KIT INCLUDING HEX WRENCH, GLUE AND INSTRUCTION FOR USE TO ALL CUSTOMERS WHO PURCHASED RT-5100 OR RT-3100. NIDEK INC. HAS ALREADY SUBMITTED RECALL REPORT (2936921-4/17/2014-001-C) DATED 04/17/2014 TO (B)(4). CONCLUSION: WE CONCLUDE THAT THE ROOT CAUSE OF FALLING DOWN OF NEAR POINT ROD (S/N (B)(4)) IS DUE TO TAKING OFF THE SCREW FOR ROTATION LIMIT (SB3X6) INTENTIONALLY FOR THE FOLLOWING REASON. "WE CONFIRMED THAT THE HINGE OF S/N (B)(4) WHICH REPLACED WAS BENT, SO WE CONCLUDED THAT SUPPORT POINT OF NEAR POINT ROD HOLDER AND HINGE GOT EXCESSIVE BURDEN. WE HAVE BEEN INFORMED THAT SCREW FOR ROTATION LIMIT (SB3X6) OF BRACKET (S/N (B)(4)) WAS TAKEN OFF. AS A RESULT OF INVESTIGATION OF RT-5100 S/N (B)(4), WE CONFIRMED THAT THE ROOT CAUSE OF FALLING DOWN OF NEAR POINT ROD (S/N (B)(4)) IS DUE TO TAKING OFF THE SCREW FOR ROTATION LIMIT (SB3X6) INTENTIONALLY." IT IS THE DESCRIPTION ABOUT THE ROOT CAUSE OF FALLEN DOWN THE NEAR POINT ROD OF S/N (B)(4). MAIN BODY CAN TURN 360 DEGREES WHEN SCREW FOR ROTATION LIMIT (SB3X6) OF BRACKET IS TAKEN OFF INTENTIONALLY. NEAR POINT ROD AND BRACKET CLASH EACH OTHER WHEN MAIN BODY WITH NEAR POINT ROD ROTATES BEYOND THE LIMIT. SUPPORT POINT OF NEAR ROD HOLDER GETS EXCESSIVE BURDEN FROM THIS CLASH. BY THE EXCESSIVE BURDEN IS REPEATED, SCREWS (HH3X3) WHICH HOLD NEAR POINT ROD HOLDER ARE LOOSE OR COME OFF. WE CONCLUDE THAT THIS ISSUE OCCURRED BECAUSE SCREW FIXATION OF NEAR POINT ROD AND HINGE ARE LOOSE, AND NEAR POINT ROD HOLDER FALLS DOWN.

    Description of Event or Problem · 1

    NIDEK CO., LTD. (B)(4) RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2013 THROUGH U.S. DISTRIBUTOR, (B)(4). RT-5100 NEAR POINT ROD FELL DOWN AND HIT THE DOCTOR'S NOSE WHEN HE USED THE RT-5100 (S/NO. (B)(4)). THE DR OBTAINED A LACERATION ON HIS NOSE. NIDEK INC. TRIED TO CONTACT THROUGH OUR DISTRIBUTOR AND MEET WITH THE DR. HOWEVER, THEIR VISIT WAS REFUSED BY THE DR BECAUSE HE THOUGHT IT WAS A NON-SERIOUS INJURY. NIDEK INC. AND (B)(4) CONFIRMED THAT HIS INJURY WAS NOT SERIOUS; THEREFORE, THERE WAS NO NEED FOR FURTHER F/U INVESTIGATION TO INJURY LEVEL AS OF (B)(6) 2013. AS NIDEK CO., LTD. INVESTIGATION THE DEVICE RETURNED, WE FOUND THE NEAR POINT ROD HOLDER WAS BENT. IT WAS EVALUATED THAT TOO MUCH PRESSURE WAS APPLIED TO THE HINGE AXIS CONNECTED TO THE NEAR POINT ROD HOLDER. AS A RESULT, THE SCREW MAY BECOME LOOSE OR THE HINGE MIGHT BE BROKEN. DURING A TELECONFERENCE WITH FDA (B)(4) OFFICE AND CDRH ON (B)(4) 2014, NIDEK INC. WAS ADVISED BY A DR IN (B)(4) THAT A COMPLAINT RELATING LACERATION OF THE NOSE WAS A SERIOUS INJURY AS SHE SAID "I WOULD CONSIDER ANY INJURY TO THE FACT THAT CAN CAUSE SCARRING A SERIOUS INJURY AND IT IS REPORTABLE." SO NIDEK INC. AND NIDEK CO., LTD. DETERMINED TO SUBMIT THIS MD TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264495 RT-5100 REFRACTOR NONE HKN NIDEK CO., LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention