MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ULTRALITE PRO MODULE; N/A

Catalog Number 001380LX

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

On 1/172017 integra investigation completed.Manufacture date not available, not integra product.Method: failure analysis, device history evaluation results: failure analysis - although the headband was integra, the headlight that was attached to the headband was not an integra headlight.The headlight is what melted, not the headband.There is no issue with the headband.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: there is no issue with the headband.

Event Description

Customer initially reports connection between the premium cable and ultralight pro headlamp melted and burned surgeon.No further information available.

• Brand Name: ULTRALITE PRO MODULE
• Type of Device: N/A
• 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: 6266090
• MDR Text Key: 65364703
• Report Number: 2523190-2017-00005
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K071218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 001380LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Date Manufacturer Received: 12/23/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR