MAUDE Adverse Event Report: PELTON & CRANE LIGHT FANTASTIC III WALL MOUNT; DENTAL LIGHT

Model Number LFIIIWL

Device Problems Break (1069); Component Falling (1105)

Patient Problem Pain (1994)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Upon visual inspection by the local pelton & crane distributor, it was determined that the positioning screw was not properly adjusted to the key on the light arm which holds the arm together.The device was not returned to pelton & crane but rather it was serviced and placed back into use at the doctor's office and has been tested and is now functioning properly.The dental light is more than 11 years old and is past the life of the device.

Event Description

A medical professional was positioning a lfiiiwl wall mount dental light away after use when the light arm broke and fell down towards the ground.The doctor pushed the light away with her hand and said her wrist hurt for one minute and then the pain went away.There were no injuries reported.

• Brand Name: LIGHT FANTASTIC III WALL MOUNT
• 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: 7118617
• MDR Text Key: 95078770
• Report Number: 1017522-2017-00069
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: LFIIIWL
• Device Catalogue Number: LFIIIWL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2006
• 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