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

Model Number HBT

Device Problem Component Falling (1105)

Patient Problems Contusion (1787); Bone Fracture(s) (1870); Pain (1994)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

The complete device was not returned to pelton & crane as the pelton & crane distributor had already repaired the dental light by replacing the counterbalance spring assembly.However, during follow-up communication with the doctors office, the replaced counterbalance spring assembly was still in the dr.'s possession therefore pelton & crane had the part returned for evaluation.Pelton & crane received the counterbalance spring assembly august 19, 2015.Upon evaluation of the spring assembly, it was identified that the two pivot studs located on both sides of the friction block were broken off due to suspected excessive loading therefore the spring assembly could not counterbalance the light head assembly.The pelton & crane dental track light was manufactured twenty-six (26) years ago in august 1989 and is past the life of the device.Furthermore, dr.(b)(6) purchased the dental track light used in 2006 from another dentist.

Event Description

A dental hygienist was performing routine dental treatment with a patient when a pelton & crane lftii dental light counter balance arm assembly failed causing the light arm to drop down towards the ground.The light arm dropped approximately one to two feet then struck the dental assistant on the right side of her head.The dental assistant went to the hospital due to feeling pain and was diagnosed with a fracture of the occipital bone and a contusion.The dental hygienist stayed in the hospital for two nights and was then released.

• Brand Name: LIGHT FANTASTIC II TRACK MOUNT 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: 5048942
• MDR Text Key: 24794579
• Report Number: 1017522-2015-00019
• 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
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Hygienist
• Device Model Number: HBT
• Device Catalogue Number: LFTII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/1989
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR