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

Model Number LFTII

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was reported that a pelton & crane dental light had come apart at the arm assembly and fell down towards the ground.No one was in the room when the event took place.

Manufacturer Narrative

The (b)(4) distributor inspected the dental light at the doctors office and was told by the dental office, the light arm rotational stop mechanism had seized together around a year ago; however, the facility continued to use the dental light without having it repaired.The function of the rotational stop is to prevent the light from rotating more than 350 degrees.As a result, the light arm assembly had rotated numerous times past 360 degrees during use allowing the light arm assembly to unscrew from the light post assembly and fall.The (b)(4)distributor repaired the light and placed it back into service.

• Brand Name: LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray, mgr ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 4156551
• MDR Text Key: 4910565
• Report Number: 1017522-2014-00014
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 09/09/2014

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: Health Professional
• Device Model Number: LFTII
• Device Catalogue Number: LFTII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2002
• 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