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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NSK NAKANISHI INC NL 4500 45 DEGREE HIGHSPEED; HANDPIECE
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NSK NAKANISHI INC NL 4500 45 DEGREE HIGHSPEED; HANDPIECE Back to Search Results
Model Number 5025051U0
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Choking (2464)
Event Date 02/18/2021
Event Type  Injury  
Event Description
The doctor was performing surgery on lower anterior ridge of 85 yr old pt with copd and emphysema.The patient was on plavix up until 5 days prior.The doctor removed 6 anterior teeth on the mandible and 2 root tips.While trying to get the root tips out with the bur, the bur touched the bone.The bur fell out of the chuck of the nl4500 handpiece and went into the patient's throat.The patient coughed and aspirated the bur.It was difficult for the patient to "catch his breath".The patient got an x-ray immediately after on the dmd's recommendation.The dmd was notified that the bur was found to be in the lower right bronchia and the total bur length is approximately 2cm.The patient will need thoracic surgery to remove the bur.The doctor was using a 557 surgical length carbide bur from another company.
 
Event Description
The doctor was performing surgery on lower anterior ridge of 85 yr old pt with copd and emphysema.The patient was on plavix up until 5 days prior.The doctor removed 6 anterior teeth on the mandible and 2 root tips.While trying to get the root tips out with the bur, the bur touched the bone.The bur fell out of the chuck of the nl4500 handpiece and went into the patient's throat.The patient coughed and aspirated the bur.It was difficult for the patient to "catch his breath".The patient got an x-ray immediately after on the dmd's recommendation.The dmd was notified that the bur was found to be in the lower right bronchia and the total bur length is approximately 2cm.The patient will need thoracic surgery to remove the bur.The doctor was using a 557 surgical length carbide bur from another company.Update: the cardiothoracic surgeon was able to surgically remove the entire bur from patients bronchi and patient is healing nicely.The office manager acknowledged that the user (assistant o-r doctor) most likely did not seat the bur entirely into the handpiece and therefore it came out and was aspirated.
 
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Brand Name
NL 4500 45 DEGREE HIGHSPEED
Type of Device
HANDPIECE
Manufacturer (Section D)
NSK NAKANISHI INC
700 shimohinata kanuma tochigi
322-8 666
JA  322-8666
MDR Report Key11373928
MDR Text Key241674188
Report Number1032227-2021-00002
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number5025051U0
Device Catalogue Number5025051U0
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2021
Distributor Facility Aware Date02/19/2021
Date Report to Manufacturer04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age85 YR
Patient Weight70
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