MAUDE Adverse Event Report: LITECURE LITECURE; THERAPEUTIC LASER

Model Number LCT-1000

Device Problems Fire (1245); Melted (1385); Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  Injury  

Event Description

Therapeutic laser cable at the connector where the cord attaches to the unit caught fire and melted due to a "short." pt treatment ceased during the occurrence.No pt injury occurred.

• Brand Name: LITECURE
• Type of Device: THERAPEUTIC LASER
• Manufacturer (Section D): LITECURE; newark DE 19702
• MDR Report Key: 6300004
• MDR Text Key: 66475148
• Report Number: MW5067628
• Device Sequence Number: 1
• Product Code: ILY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LCT-1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IDENTIFYING MARKS: (B)(4); LASER TREATMENT HEAD AND CORD,
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 82