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

Model Number HBC

Device Problem Installation-Related Problem (2965)

Patient Problem Contusion (1787)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the distributor service technician 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 ceiling mounted tripod assembly after installation.The pelton & crane installation instructions clearly states to properly install the roll pins during installation of the ceiling mounted dental light.The installation instructions also lists warnings to ensure the roll pins are installed.The pelton & crane ceiling mounted dental light is over 24 years old and past the life of the device.

Event Description

It was reported to kavo dental technologies, llc that a pelton & crane lfcii dental light fell dowm from the ceiling and was defected away by the dr.During routine patient dental treatment causing a small bruise to the doctor's arm.There were no serious injuries reported.

• Brand Name: LIGHT FANTASTIC
• 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: 8088738
• MDR Text Key: 127878269
• Report Number: 1017522-2018-00031
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HBC
• Device Catalogue Number: LFCII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/1994
• 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