MAUDE Adverse Event Report: LITECURE, LLC LIGHTFORCE; THERAPY LASER

Model Number	LTS-2500
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	01/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device returned for evaluation and no quality issues found.Device safety functions and performance were within specifications.Reported injury caused by known risk inherent with device type and documented in labeling and risk management.Incident type will be further analyzed through post market surveillance process.
Event or Problem Description
Patient experienced lesion on shoulder several days after treatment due to incorrect procedure by operator.The provided dose was greater than the recommended level leading to overexposure.Treatment technique did not follow ifu.Also, patient had reduced sensation due to existing condition that was not disclosed prior to treatment.

• Brand Name: LIGHTFORCE
• Common Device Name: THERAPY LASER
• Manufacturer (Section D): LITECURE, LLC; 101 lukens dr; suite a; new castle DE 19720 2791
• MDR Report Key: 8437526
• Report Number: 3006268867-2019-00001
• Device Sequence Number: 16704878
• Product Code: ILY
• UDI-Device Identifier: 00854103007059
• UDI-Public: (01)00854103007059(11)180418
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K173067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: LTS-2500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR