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

Model Number HL3C

Device Problem Installation-Related Problem (2965)

Patient Problem Swelling (2091)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the pelton & crane authorized distributor it was determined the light arm set screw was not properly installed by the distributor during installation.The set screws will prevent the light from unscrewing from the light arm after installation.The pelton & crane installation instructions clearly states to properly install and secure the set screws during installation of the dental light.The installation instructions also lists warnings to ensure the set screws are installed and properly secured.Pelton & crance shipped set screws to the authorized pelton & crane dealer for installation on the dental light.

Event Description

A dental assistant was cleaning a pelton & crane helios dental light when the light came apart and fell down towards the floor hitting the dental assistant on the side of the head causing a bump.There were no serious injuries reported.

• Brand Name: HELIOS
• 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: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 8054586
• MDR Text Key: 126648486
• Report Number: 1017522-2018-00028
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL3C
• Device Catalogue Number: HL3C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2013
• 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: 25 YR