MAUDE Adverse Event Report: LARES RESEARCH LARES 757 ULTRALITE HIGH-SPEED HANDPIECE; AIR DRIVEN HIGH-SPEED DENTAL HANDPIECE

Model Number 757 ULTRALITE

Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Material Separation (1562)

Patient Problems Pain (1994); Injury (2348); Foreign Body In Patient (2687)

Event Date 07/20/2011

Event Type  malfunction  

Event Description

Last year, (b)(6) 2011, i had a turbine explode while the lares hs was in use on a crown prep, and i wrote you about it.I sent you the turbine and chuck, which lures kept.The pt came in today and showed me a radiograph of a dental bur hung in her right lung.After the turbine and chuck separated from the turbine, i told the pt what happened and asked her if she would to the physician and have herself checked (x-rays).The pt declined.She was in an auto accident in (b)(6) 2012 and broke some ribs.The attached radiograph showed the bur.She was asymptomatic for a full year with the bur hung in her lung.She says it now burns.

Manufacturer Narrative

Event report manufacturer's observations on 07/20/2011: handpiece serial no: (b)(4) ultralite swivel model.Diffuser was in place.Head cap tight.A non-lares manufactured rotor assembly was installed in the head.Significant dynamic contact markings were on the inside diameter of diffuser.Internal components of non lares chucking system were received separate from handpiece.No record of any medical intervention in (b)(4) 2011 event report.Product was repaired using new oem turbine rotor and was returned to svc on repair order no: (b)(4).Subsequent notification of medical intervention for (b)(4) 2011 event report received by manufacturer on 09/26/2012 from practitioner.

• Brand Name: LARES 757 ULTRALITE HIGH-SPEED HANDPIECE
• Type of Device: AIR DRIVEN HIGH-SPEED DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; chico CA
• Manufacturer Contact: jason orgain ; 295 lockheed ave.; chico, CA 95973 ; 5303451767
• MDR Report Key: 4009122
• MDR Text Key: 4691979
• Report Number: 2916440-2012-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 757 ULTRALITE
• Device Catalogue Number: 10305-221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1