MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC TRACK MOUNTED DENTAL LIGHT

Model Number HL3T

Device Problem Device Fell (4014)

Patient Problem Pain (1994)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation to date.Attempts are being made to have the light returned for evaluation and if the device is returned, an evaluation will be performed, and a follow up report submitted.

Event Description

It was reported that at the time of the event, a patient was in the room in the dental chair and the dental assistant was standing behind the patient.The light was semi folded and to the side of the patient, the light fell striking the dental assistant on the right shoulder and right hand.The light did not hit the patient and the light was not in use at the time of the incident.The light broke/came apart at the elbow/bend in the mechanical arm.Once the light fell and hit the floor, the head broke at the handle/yoke.The dental assistant went to the local urgent care for treatment and her arm was put in a splint.The dental assistant chose not to return to work after the incident.

Manufacturer Narrative

The dentist returned the dental light to kavo dental technologies, llc (dba pelton & crane) on (b)(6) 2021 for evaluation.As a result of the evaluation it was determined that the roll pin and 2 of 4 set screws were not properly installed by the distributor during installation.The roll pins and set screws will prevent the light from unscrewing from the trolley and/or post after installation.The pelton & crane installation instructions clearly states to properly install the roll pins and set screws during installation of the track light.The installation instructions also lists warnings to ensure the roll pins and set screws are installed.(b)(6) (pelton & crane quality specialist) contacted the dr's office on (b)(6) 2021 and spoke with danielle with the front office, and informed danielle that the cause of failure was due to improper installation by her dealer.This concludes the investigation.

• Brand Name: TRACK MOUNTED DENTAL LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• MDR Report Key: 11854243
• MDR Text Key: 251656918
• Report Number: 1017522-2021-00001
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

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: 0.842.4800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other