MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; 757 WORKHORSE

Model Number 757 WORKHORSE

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined non-lares manufactured parts were installed on the device.

Event Description

High-speed handpiece button came off in patient's mouth during dental procedure but was successfully retrieved.No injury or further medical intervention was required.

• Brand Name: LARES RESEARCH
• Type of Device: 757 WORKHORSE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed ave; chico CA 95973
• Manufacturer (Section G): LARES RESEARCH; 295 lockheed ave; chico CA 95973
• Manufacturer Contact: bruce holderbein ; 295 lockheed ave; chico, CA 95973 ; 5303451767
• MDR Report Key: 11219481
• MDR Text Key: 233498518
• Report Number: 2916440-2021-00001
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 757 WORKHORSE
• Device Catalogue Number: 10321-021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1