MAUDE Adverse Event Report: MIDMARK CORPORATION ELEVANCE L/R LED DENTAL LIGHT; DENTAL LED LIGHT

Model Number 153901-002

Device Problem Component Falling (1105)

Patient Problem Suture Abrasion (2497)

Event Date 07/08/2017

Event Type  Injury  

Manufacturer Narrative

After review of pictures of the incident provided by the user facility the following explanation is the most likely cause of the light falling: the upper l/r light arm was out at a 90 degree angle from the dental chair toward a half-wall that was within the range of the light arm.When the dental chair was being lowered while the light was in this position, the light assembly would get caught on the half-wall which would cause the upper l/r arm to raise out of the joint.This would allow the light assembly and upper l/r arm to separate from lower l/r arm and tip toward the patient sitting in the dental chair.Additionally, the user facility stated they would not send the unit back for evaluation as they decided to assemble the dental light back together and resume using it.No servicing or replacements components were requested by the user facility.

Event Description

During a root canal procedure, the l/r led dental light fell on the head of a patient, cutting the patient's head.The doctor present at that time stitched up the laceration.

• Brand Name: ELEVANCE L/R LED DENTAL LIGHT
• Type of Device: DENTAL LED LIGHT
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: adam clutter ; 60 vista drive; versailles, OH 45380 ; 9375268474
• MDR Report Key: 6801679
• MDR Text Key: 82957408
• Report Number: 1523530-2017-00003
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 153901-002
• Device Catalogue Number: 153901-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• 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