FDA.reportPublic FDA data

MAUDE MDR 8484700

MDR report key
8484700
Report number
9611253-2019-00021
Event key
0
Event type
3
Date of event
2019-03-01
Date received
2019-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR KENNETH BLOCK
Address
800 E CAMPBELL RD. SUITE 202 RICHARDSON TX 75081 US
Phone
972-972-9724
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NSKHANDPIECE, ROTARY BONE CUTTINGNAKANISHI INC.KMWX-SG65LH1009Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0401. O

Event Narratives#

N

Patient 1

NAKANISHI IS STILL TRYING TO OBTAIN MISSING INFORMATION ABOUT THE PATIENT.

D

Patient 1

ON MARCH 14, 2019, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A HANDPIECE OVERHEATING. ACCORDING TO THE DISTRIBUTOR, ONE OF THE X-SG65L HANDPIECES (SERIAL NO. (B)(4)) OVERHEATED AND CAUSED THE FOLLOWING EVENT, BUT THE DENTIST COULD NOT IDENTIFY WHICH DEVICES ACTUALLY OVERHEATED. THE DETAILS OF THE EVENT ARE: THE EVENT OCCURRED ON (B)(6) 2019. THE SURGEON WAS REMOVING THE 3RD MOLAR OF THE PATIENT'S LOWER RIGHT JAW USING THE X-SG65L HANDPIECE. THE PATIENT WAS UNDER ANESTHESIA. DURING THE PROCEDURE, THE HANDPIECE SUDDENLY MADE AN ABNORMAL NOISE AND STOPPED. THE DENTIST NOTICED THAT OIL HAD GOTTEN ONTO HIS/HER GLOVES AND ONTO THE PATIENT'S UPPER LEFT LIP. WHEN REMOVING THE HANDPIECE FROM THE PATIENT'S MOUTH, THERE WAS A BURN ON THE PATIENT'S LIP. THE SURGEON IMMEDIATELY STOPPED THE SURGERY, IRRIGATED THE WOUND AND APPLIED (B)(6) TO THE AREA. THE SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE, AS THE HANDPIECE INVOLVED IN THE EVENT WAS NO LONGER FUNCTIONING. THE SURGEON REPORTED THAT THERE WAS SIGNIFICANT OIL COMING OUT OF THE HANDPIECE WHEN THE DEVICE WAS CLEANED BY THE STAFF LATER. THE SURGEON CONSULTED OTHER MEDICAL STAFF IN THE HOSPITAL, AND THE HEAD OF PLASTIC SURGERY RECOMMENDED KENALOG IN OROBASE. THE HOSPITAL DETERMINED THAT NO IMMEDIATE BURN TREATMENT WAS NECESSARY AND THAT THE HOSPITAL WOULD CONDUCT A FOLLOW-UP WITH THE PATIENT. NAKANISHI IS SUBMITTING TWO SEPARATE MDRS FOR THIS EVENT BASED ON THE INFORMATION FROM THE DISTRIBUTOR. THIS MDR IS REGARDING THE HANDPIECE WITH THE SERIAL NUMBER (B)(4).