MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC HELIOS 3000 LIGHT; DENTAL LIGHT

Model Number HL3T

Device Problem Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Dealer technician called kavo dental technologies, llc and stated that a pelton & crane helios track light fell down towards the floor.The doctor's office confirmed the light arm grazed the right calf area of the patient's leg with no obvious signs of trauma.There were no serious injuries or medical intervention reported.

Manufacturer Narrative

Upon evaluation by the distributor it was determined that the dental light was not installed in accordance to the pelton & crane manufacturer's install instructions because the roll pin and set screws were not properly installed per the installation instructions.The roll pin and set screws will prevent the light from unscrewing from the column after installation.The pelton & crane installation instructions clearly states to properly install the roll pins and set screws during installation of the track mounted light.The installation instructions also list warnings to ensure the roll pins and set screws are installed.The authorized pelton & crane dealer reinstalled the light confirming proper installment with the roll pin and set screws per the installation instructions.This concludes the investigation.

• Brand Name: HELIOS 3000 LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 18574350
• MDR Text Key: 334671211
• Report Number: 1017522-2024-00001
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL3T
• Device Catalogue Number: 0.848.5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2011
• 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
• Patient Age: 56 YR
• Patient Sex: Female