NSK SGA-E2S H265

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-20 for NSK SGA-E2S H265 manufactured by Nakanishi Inc..

Event Text Entries

[131143951] (b)(4). Nakanishi is currently trying to obtain further information about the event and patient.
Patient Sequence No: 1, Text Type: N, H10


[131143952] On december 5, 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611253-2018-00069
MDR Report Key8186538
Report SourceDISTRIBUTOR
Date Received2018-12-20
Date of Report2018-12-20
Date of Event2015-07-01
Report Date2018-12-05
Date Reported to Mfgr2018-12-05
Date Mfgr Received2018-12-05
Date Added to Maude2018-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KENNETH BLOCK
Manufacturer Street800 E CAMPBELL RD. SUITE 202
Manufacturer CityRICHARDSON TX 75081
Manufacturer CountryUS
Manufacturer Postal75081
Manufacturer Phone9724809554
Manufacturer G1NAKANISHI INC. REGISTRATION NUMBER : 9611253
Manufacturer StreetMFR RPT# : 9611253-2018-00069 700 SHIMOHINATA
Manufacturer CityKANUMA-SHI, TOCHIGI-KEN 322-8666
Manufacturer CountryJA
Manufacturer Postal Code322-8666
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number9611253-060818-001-R
Event Type3
Type of Report3

Device Details

Brand NameNSK
Generic NameHANDPIECE, ROTARY BONE CUTTING
Product CodeKMW
Date Received2018-12-20
Model NumberSGA-E2S
Catalog NumberH265
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNAKANISHI INC.
Manufacturer Address700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-12-20

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