BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK TI-57

    MDR report key: 4212546 · Received October 24, 2014

    Report

    Report Number
    9611253-2014-00014
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    August 22, 2013
    Report Date
    October 23, 2014
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K962540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (TI57, SERIAL NO. (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. (B)(4) CONCLUSION: UNABLE TO DETERMINE ROOT CAUSE, BUT MAY BE RELATED TO MAINTENANCE. (B)(4) DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM (B)(4) DISTRIBUTOR OF THE NAKANISHI INC (NSK) HANDPIECE. (B)(4) EVENT SUMMARY: THE CUSTOMER NOTED THAT THE PATIENT BIT DOWN DURING THE PROCEDURE AND SWALLOWED PART OF THE HANDPIECE AND THE PROPHY CUP. THE UNIT WAS PURCHASED (B)(6) 2006, AND WAS ABOUT 81 MONTHS OLD AS OF THE DATE OF THE COMPLAINT. THERE IS NO RECORD OF REPAIR FOR THIS UNIT PRIOR TO THIS COMPLAINT. PATIENT WAS TAKEN FOR X-RAYS; PARTS WERE IN THE STOMACH AND WILL PASS. (B)(4) INVESTIGATION: WHEN THE UNIT WAS EVALUATED BY THE REPAIR DEPARTMENT, THE SCREW SHAFT AND THE END CAP WAS MISSING FROM THE UNIT. THE BEARING IN THE PLANETARY GEAR HOLDER ASSEMBLY AND THE DOG CLUTCH WERE BAD. THE CUSTOMER WAS PROVIDED A QUOTE FOR THE REPAIR, BUT DECIDED TO DENY THE REPAIR. THE UNIT WAS RETURNED TO THE CUSTOMER UNREPAIRED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679559 NSK TI-57 HANDPIECE, CONTRA AND RIGHT ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) TI57

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR