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

Model Number HBT

Device Problem Component Falling (1105)

Patient Problem Laceration(s) (1946)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the distributor, it was determined the roll pins and set screws were not installed by the distributor during installation.The roll pins and set screws prevents the light from unscrewing from the trolley after installation.The distributor service technician ordered the roll pins and set screws and properly installed them on the dental light.The dental light was manufactured in may 1979 and is over 38 years old and past the expected life of the device.

Event Description

It was reported that a pelton & crane dental light fell from the track assembly and struck the patient on the head causing a small laceration above the patients eye.General first aid was provided only.There were no serious injuries reported.

• Brand Name: LIGHT FANTASTIC II TRACK MOUNTED DENTAL 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: 6742387
• MDR Text Key: 81245357
• Report Number: 1017522-2017-00037
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Hygienist
• Device Model Number: HBT
• Device Catalogue Number: LFTII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/1979
• 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