MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC HELIOS 1800 TRACK MOUNTED LIGHT; DENTAL LIGHT

Model Number HLT

Device Problem Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the distributor it was determined the roll pins were not installed by the distributor during installation.The roll pins will prevent the light from unscrewing from the trolley after installation.The pelton & crane installation instructions clearly states to properly install the roll pins during installation of the track light.The installation instructions also list warnings to ensure the roll pins are installed.Pelton & crane shipped the roll pins to the authorized pelton & crane dealer to properly install the dental light per the installation instructions.This concludes the investigation.

Event Description

Dealer technician called kavo dental technologies, llc and stated that a pelton & crane helios track light fell down towards the floor hitting the patient on their knee causing a bruise.There were no serious injuries reported.

• Brand Name: HELIOS 1800 TRACK MOUNTED 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: 12168609
• MDR Text Key: 263862694
• Report Number: 1017522-2021-00003
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLT
• Device Catalogue Number: 0.848.5100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• 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