MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LED HEADLIGHT ONLY; LIGHTING

Catalog Number 90500

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports a short in device and burning smell.On (b)(6) 2017 foot procedure being performed.Customer has no further information.

Manufacturer Narrative

On 2/23/17 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation results: failure analysis - functional test found the headlight powered "on" but, the light intensity was not adjustable by the control knob.A burnt, component smell was evident.Inspection of the internal components of the rear module assembly found a burnt component toward the edge of printed circuit board (pcb).The pcb was also, burnt at that location.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the complaint report was confirmed.The root cause was not conclusively determined.The returned 90500 led headlight was repaired and will be returned to the customer.No manufacturing, workmanship, or material deficiency has been identified.

• Brand Name: LED HEADLIGHT ONLY
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6329608
• MDR Text Key: 67394861
• Report Number: 2523190-2017-00015
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: K110528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1