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

Catalog Number 00MLX

Device Problems Arcing (2583); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports weak light on the lamp.There were sparkles upon startup and it emitted a jarring sound.On 10/27/16 no further information available.

Manufacturer Narrative

On 12/22/2016 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis; during investigation we have observed that the unit did not power on and there were also some sparkle seen.Device history evaluation: nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: none.Health hazard evaluation history: none.Conclusion: the reported issue was confirmed, unit was repaired and returned to customer.Our records indicate a potentially related cause.There has been a corrective action request initiated to address this issue and prevent its recurrence.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6110259
• MDR Text Key: 60294813
• Report Number: 2523190-2016-00186
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• 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: 10/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2016
• 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