BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1244977 · Received November 18, 2008

    Report

    Report Number
    9611253-2008-00002
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    April 1, 2008
    Report Date
    November 18, 2008
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EFB
    PMA / PMN Number
    K962543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NSK HAS NOT HAD AN OPPORTUNITY TO REVIEW THE HANDPIECE AT ISSUE, WHICH CANNOT BE LOCATED AT PRESENT. HOWEVER, SHORTLY PRIOR TO THE INCIDENT, THE HANDPIECE WAS REPAIRED BY AN UNAFFILITATED THIRD PARTY REPAIR SHOP OVER WHICH NSK HAS NO CONTROL (B) (4). THE REPAIR SHOP REPORTS THAT NSK PARTS WERE USED IN THE REPAIR, BUT IT IS UNABLE TO PROVIDE ANY SERIAL NUMBERS FOR SUCH PARTS AND THUS NSK IS UNABLE TO CONFIRM WHETHER GENUINE PARTS WERE ACTUALLY USED. THIS REPAIR SHOP IS KNOWN TO HAVE USED NON-NSK PARTS IN ITS REPAIR WORK IN THE PAST. THUS, IT IS POSSIBLE THAT A FAULTY REPAIR OR A REPAIR USING NON-GENUINE NSK PARTS WAS THE CONTRIBUTING FACTOR TO THIS INCIDENT. NSK TESTS EVERY CARTRIDGE (TURBINE) FOR BUR RETENTION BEFORE SHIPMENT, AND HAS NO REASON TO SUSPECT THAT THIS PARTICULAR UNIT WAS DEFECTIVE OR HAD ANY FLAW.

    Description of Event or Problem · 1

    A DENTAL HANDPIECE THAT HAD BEEN RECENTLY REPAIRED BY A THIRD PARTY UNAFFILIATED WITH THE MFR DID NOT RETAIN A BUR DURING A DENTAL PROCEDURE, REPORTEDLY RESULTING IN THE PATIENT SWALLOWING AND/OR ASPIRATING THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE EFB NAKANISHI, INC. NSK NL85S

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other