MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MLX 300W XENON LIGHTSOURCE; N/A

Catalog Number 00MLX

Device Problems Thermal Decomposition of Device (1071); Device Sensing Problem (2917)

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

Event Date 03/16/2016

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 reports that unit got hot enough to burn a hole through 2 headlight modules, two separate patient procedures.They were using the 001380lx9 cables.On (b)(6) 2016 customer has not provided additional promised information.Two of 2 related complaints (other report#2523190-2016-00059).

Manufacturer Narrative

The 6/21/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - lamp is discolored.Control board failed error code sequence and memory.A visual inspection found that the turret is melted at the wolf port and the four bumper feet were missing.The turret, control board and 4 bumper feet were replaced during the repair.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 is confirmed.The unit was repaired and returned to customer.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• 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: 5555719
• MDR Text Key: 42160639
• Report Number: 2523190-2016-00060
• Device Sequence Number: 1
• Product Code: FCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• 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