BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 8186537 · Received December 20, 2018

    Report

    Report Number
    9611253-2018-00066
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    July 1, 2015
    Report Date
    August 5, 2019
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    PMA / PMN Number
    K171155
    Removal / Correction Number
    9611253-060818-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    NSK AMERICA (NAM) TOOK THE FOLLOWING ACTIONS, BUT FURTHER INFORMATION ABOUT THE EVENT AND PATIENT WAS NOT PROVIDED FROM THE DENTIST. - ON DECEMBER 14, 2018, NAM MADE A PHONE CALL TO THE DENTAL OFFICE. - ON JANUARY 29, 2019, NAM SENT AN E-MAIL TO THE DENTIST. - ON MAY 28, 2019, NAM SENT ANOTHER E-MAIL TO THE DENTIST.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016004. (B)(4). NAKANISHI IS CURRENTLY TRYING TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT AND PATIENT.

    Additional Manufacturer Narrative · 0

    ON JULY 20, 2019, NAKANISHI WAS INFORMED BY THE DISTRIBUTOR (NAM) THAT NAM HAD TAKEN THE FOLLOWING ACTIONS AS A PART OF THE IFU RECALL ACTIVITIES. ON OCTOBER 15, 2018, NAM SENT THE UPDATED OPERATION MANUALS THAT CONTAIN THE DETAILED REPROCESSING METHOD TO THE DENTAL OFFICE TO PREVENT THE DEVICES FROM OVERHEATING. ON OCTOBER 22, 2018, NAM CONFIRMED THE RECEIPT OF THE OPERATION MANUALS BY THE DENTIST THROUGH USPS CERTIFIED RECEIPT.

    Description of Event or Problem · 0

    ON (B)(6) 2018, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR (B)(4) ABOUT A HANDPIECE OVERHEATING. ACCORDING TO (B)(4), THE INFORMATION WAS PROVIDED THROUGH THE ADVERSE EVENT QUESTIONNAIRE ABOUT THE SGS/SGA HANDPIECES AS A PART OF RECALL ACTIVITIES FOR THOSE DEVICES. THE DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED IN (B)(6) 2015. (THE EXACT DATE IS UNKNOWN). A DENTIST WAS PERFORMING A DENTAL PROCEDURE USING THE SGA-E2S HANDPIECE (SERIAL NO. UNKNOWN). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED AND BURNED A PATIENT'S LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025842 NSK HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC. SGA-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other