MAUDE Adverse Event Report: PELTON & CRANE LIGHT FANTASTIC II TRACK LIGHT; DENTAL LIGHT

Model Number HBT

Device Problem Unintended Collision (1429)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

The distributor replaced the spring assembly but accidentally disposed of the replaced component instead of returning it to pelton & crane for evaluation.The dental light is over 15 years old and is pasted the life of the device.

Event Description

A dental professional was using a pelton & crane dental light when the counter balance arm assembly broke and dropped down towards the floor resulting in the light head contacting the back of the patients head.There were no injuries reported.

• Brand Name: LIGHT FANTASTIC II TRACK LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 5497317
• MDR Text Key: 40650260
• Report Number: 1017522-2016-00005
• 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: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: HBT
• Device Catalogue Number: LFTII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2001
• 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: 57 YR