MAUDE Adverse Event Report: PELTON & CRANE HELIOS 3000 TRACK MOUNTED DENTAL LIGHT; DELTAL LIGHT

Model Number HL3T

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problem Swelling (2091)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Upon evaluation by the distributor it was determined the roll pins were not installed during installation of the track light.The roll pins prevent the light from unscrewing from the trolley after installation.The pelton & crane installation instructions clearly states to properly install the roll pins during installation of the track light.The installation instructions also list warnings to ensure the roll pins are installed.The distributor confirmed that the replacement parts were received and properly installed to resolve this issue.The returned parts were evaluated, and it was confirmed that the roll pins were not installed.Set screw dents were visible on both ends of the light column but the roll pins holes were never drilled on either end of the light column.This required safety feature was not installed resulting in the light column unscrewing over time.In conclusion the light column and coupling were not properly installed.Helios light installation manual states "failure to install set screws & roll pin per installation instructions could result in injury or damage to equipment".This concludes the investigation.

Event Description

It was reported that the track light fell and hit the patient on the left leg when the doctor pulled the light toward the patient's head.The office staff applied an ice pack and gave him baby motrin.The mother took him to the doctor, who said no physical education class for 1 week.There were no bruises.His left leg is sore when he walks.

• Brand Name: HELIOS 3000 TRACK MOUNTED DENTAL LIGHT
• Type of Device: DELTAL LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 9484027
• MDR Text Key: 241260805
• Report Number: 1017522-2019-00019
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL3T
• Device Catalogue Number: HL3T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2010
• 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): Other
• Patient Age: 11 YR