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

Model Number HLT

Device Problem Installation-Related Problem (2965)

Patient Problem Swelling (2091)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the distributor, it was determined the roll pins were not installed by the distributor during installation and the set screws were loose and not properly secured.The roll pins and set screws will prevent the light from unscrewing from the trolley after installation.The pelton & crane installation instructions clearly states to properly install the roll pins and set screws during installation of the track light.The installation instructions also lists warnings to ensure the roll pins and set screws are installed.Pelton & crance shipped roll pins and set screws directly to the doctors office who has been instructed to have his authorized pelton & crane dealer install them on his helios dental light.

Event Description

A dental assistant was positioning away from use a helios track mounted dental light when the light fell from the trolly towards the floor.The dental assistant pushed the light away from the patient when it fell.The patient told the dental assistant the light did not hit them but later told the dr.The light did hit them on the head and caused a small bump.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: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 7758225
• MDR Text Key: 116388401
• Report Number: 1017522-2018-00022
• 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,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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: HLT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• 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: 42 YR